Pharmaceuticals
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Cannabis for veterinary patients gets research attention, funding
3/29/2018
Stigma begins to lift but legal questions persist
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Hurricane Maria's effects minimal on veterinary drug supply
12/18/2017
But sterile IV bags reportedly on back order
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FDA backs off veterinary drug compounding approach
11/7/2017
Limbo on intractable issue continues
-
Key veterinary euthanasia drugs in short supply
10/20/2017
FDA takes steps to ease the problem
-
Should botanical medicine be a formal veterinary specialty?
8/25/2017
As Sept. 1 deadline for comments nears, practitioners debate
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Lawyer anticipates plea agreement in veterinary-drug case
6/2/2017
Sean Gerson accused of illegal internet sales
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Confusion ensues during veterinary-compounding discussion
5/2/2017
California regulators grapple with applying new rules
-
Suspect admits to burglarizing veterinary clinics
4/18/2017
Lured by value of flea-and-tick products
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Marketer of generic heartworm drug for dogs promises stable supply
3/15/2017
Brand-name Immiticide was plagued by shortages; will Diroban be different?
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FDA completes step in fight against antimicrobial resistance
2/16/2017
Agency also finds slowing rate of growth in drug sales, distribution
-
Pet-drug salesman Sean Gerson pleads not guilty
1/19/2017
Arraigned in federal court on felony and misdemeanor charges
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Big gets bigger in 2016
12/29/2016
Year-end snapshot of noteworthy business deals in animal-health market
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Veterinary-drugs seller Sean Gerson arrested
12/16/2016
FDA agent tracked supplier for five years
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Drug maker's leptospirosis claims surprise veterinarians
9/29/2016
Zoetis ad for novel vaccine shows high numbers of exposed horses
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Veterinary-drugs peddler eludes justice
9/19/2016
Sean Gerson remains in business despite years of pursuit
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Pet pharmacy Rx transfers: supporting the competition?
7/14/2016
Veterinarian pushes Vets First Choice for greater transparency
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UN rejects bid for global ketamine ban
5/27/2016
Veterinarians petition to protect ketamine access
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Veterinary prescription practices reviewed by House panel
4/29/2016
Lawmakers profess affection for pets, appreciation of veterinarians
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House subcommittee to consider pet-prescription rules
4/28/2016
Proposed ‘Fairness to Pet Owners Act’ a subtext of hearing Friday
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Zeuterin marketer falters two years after U.S. debut
4/22/2016
Sales of injectable sterilant for dogs come up short
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Drug options for low thyroid in dogs to shrink sharply
3/10/2016
FDA targets long-used but unapproved medications
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Veterinary community rallies to combat burglaries
9/25/2015
Thieves target flea, tick, heartworm products
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Veterinary generics squeezed by blocking agreements
9/8/2015
Zoetis, Merial bar big distributors from selling competing generic drugs
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Popular as ever, veterinary compounding poised for change
8/6/2015
Following long limbo, FDA proposes new approach
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FTC: Pet-medications market could be more competitive
5/27/2015
Consumers would benefit from broader prescription portability, report says
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FDA releases draft guidance on animal drug compounding
5/18/2015
Proposed policy lays out new rules for veterinarians
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Accidental pet exposures to hormones: purveyors respond
4/2/2015
Reactions range from nonchalance to concern
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Fur loss in dogs linked to owners’ hormone use
3/17/2015
Veterinarian suspects unwitting exposure persists
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MWI sale reflects trend in pet-related industries
1/27/2015
Veterinarians wonder how service, prices will fare
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Interceptor parasite preventive returning to market
1/20/2015
New owner Elanco cites popular demand
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Sale of pet-supply company sign of changing times
12/17/2014
Petco purchase of Drs. Foster and Smith one of several industry shifts
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Ownership of Sentinel antiparasitic line poised to change
10/31/2014
Virbac seeks Novartis veterinary drugs in transaction with Eli Lilly
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Controlled-drugs disposal options expanded
9/23/2014
New federal rules take effect Oct. 9
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Rumored price hikes, rationing send veterinarians scrambling for saline
7/10/2014
Hoarding prompts suppliers to allocate saline, insider says
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Fate of Novartis portfolio in question after sale to Eli Lilly
6/27/2014
Deal creates world's second-largest animal health business
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Lantus prices squeeze veterinarians and owners of diabetic cats
2/21/2014
Patent woes, generic insulins on horizon
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Pharmacies asked to use state license numbers to identify veterinarians
11/21/2013
Industry group urges substitute for inappropriate use of DEA number
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Does illegal OTC drug use by pet owners contribute to heartworm resistance?
11/18/2013
Differing rules for pet, livestock antiparasitic products questioned
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Online veterinary pharmacy automates drug recommendations
10/2/2013
Legal marketing tactic or unlicensed medical practice?
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FDA eases restrictions for ProHeart 6 following safety review
9/30/2013
Veterinarians no longer need signed consent to use heartworm drug
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Pharmacist admonished in veterinary case
9/5/2013
He needlessly alarmed pet owner about prescription, regulators found
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Heartworm drug resistance: It's real
8/19/2013
All preventive drugs on market implicated, scientists say
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Navigating bewildering array of pet antiparasitics
8/15/2013
Experts advise against one-size-fits-all approach
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Repackaged veterinary drugs raise eyebrows
8/13/2013
Branding or an attempt to circumvent tracking?
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Some veterinarians wary of Novartis’ enticements to carry Sentinel
5/9/2013
Interceptor gone forever, company says
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Vetsulin back with label changes
5/3/2013
Surprising new instructions: ‘shake’ drug to mix
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Panel airs FDA restrictions on livestock antibiotics use
4/25/2013
Achieving greater veterinary oversight not simple
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Changing insulin brands may disrupt diabetics
2/5/2013
Problems in veterinary patients highlight heedless switching
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Veterinary prescription problems aired with regulators
1/12/2013
Pharmacy boards urge veterinarians to file complaints
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Company pursues first lymphoma drug for dogs
1/2/2013
$1.5 million raised to fund effort
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Insiders lift veil off veterinary drug distribution practices
9/25/2012
Upcoming FTC meeting prompts disclosures
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Novartis pleads with veterinarians: ‘Save us a spot’
8/29/2012
Interceptor, Sentinel found online but not in veterinary practices
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Future of Novartis anti-parasitics unfolding
8/23/2012
FDA approves new versions of Interceptor, Sentinel
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Accreditation body questions pharmacies on veterinary drug suppliers
6/28/2012
Vet-VIPPS applications said to be suspended during investigation
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Veterinarians say pharmacists change prescriptions without asking
6/18/2012
Retailers' foray into pet drugs causes rising tensions
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More legal turns in push to restrict antibiotics in livestock
6/12/2012
Disease prevention uses in dispute
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Franck's recall triggered by rash of fungal eye infections
5/29/2012
Pharmacy's ophthalmic drops, parenteral medications included
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Veterinarian opens up about going undercover
5/22/2012
Flea-product diversion adventure twisted, turned
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Merial: PureVax for ferrets coming back this week
4/30/2012
Backorder of distemper vaccine stirred worries
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Judge orders FDA to assess antibiotic safety in livestock
4/2/2012
AVMA responds with support for the judicious use of antimicrobials
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Veterinarians frustrated by Novartis backorders
3/26/2012
Practitioners face supply problems tied to generics-maker Sandoz
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Novartis warns veterinarians of possible Clomicalm tablet mixups
2/1/2012
FDA chastises company, prompts plant shutdown
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Veterinarians confront Internet pharmacy PetMed Express
1/16/2012
Company acknowledges: ‘Some mistakes were made’
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FDA limits cephalosporin use in livestock to curb drug resistance
1/6/2012
AVMA calls new restrictions reasonable
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Novartis temporarily suspends production of Interceptor, Sentinel
12/29/2011
Supply of other, unnamed drugs also impacted by plant improvements
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PetMed Express stumbles
12/8/2011
Competitive pressure up in veterinary-drug sales
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DOJ challenges ruling in veterinary compounding case
11/16/2011
Appeal sought of decision that restricted FDA's authority
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Veterinary compounding out of FDA’s jurisdiction, judge rules
9/13/2011
Franck's wins legal battle against federal regulators
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Immiticide supplies run dry
8/9/2011
New guidance from the American Heartworm Society expected
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Pfizer seeks to unload animal health division
7/8/2011
Sale or spin-off expected
-
Gilded Lilly? Bayer challenges Elanco claims
6/24/2011
Bayer challenges Elanco claims about diversion, loyalty to veterinarians
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Researcher promotes awareness of accidental hormone exposure in pets
6/8/2011
VIN tallies more than 100 case reports since 2003
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Scientist fired by Merial alleges Heartgard Plus coverup
6/7/2011
Dr. Kari Blaho-Owens seeks damages, whistleblower protections
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Antibiotics: spinning the data from Denmark
5/27/2011
Antibiotics do little to enhance growth, yet producers still use them
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Antibiotics: precaution vs. proof
5/26/2011
Weighing risk to public health from antibiotics used in livestock
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FDA: Food-animal antibiotic consumption dwarfs human medical use
5/25/2011
New data reveal flaws in figures presented by AVMA, industry
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Scrutiny of livestock antibiotic use pressures veterinary profession
5/24/2011
AVMA negotiates shifting regulatory landscape
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Online veterinary pharmacies exploit cross-border regulatory gaps
4/25/2011
Canine heartworm prevention drugs sold without required prescription
-
'Party times over for flea and tick killer ProMeris
4/21/2011
Pfizer plans to discontinue product in September
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Animal health companies move toward consolidation
4/12/2011
Trend promises to impact veterinary medicine
-
Silver lining for veterinary medicine in failed union of pharmaceutical giants
4/11/2011
Competition between drug makers a positive for the profession, experts say
-
Shar-Pei owners given affordable access to human drug
4/8/2011
Extreme price hike on colchicine caused stir
-
Phenobarbital labeling mix-up results in recall, adverse events
3/10/2011
Veterinarians warned of mislabled Qualitest Pharmaceuticals tablets
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Future of veterinary compounding hangs in balance
2/25/2011
Judge hits federal government with tough questions
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Glycopyrrolate shortage hits human, veterinary medicine
2/24/2011
Atropine suggested as a replacement
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Campaign to defend veterinary compounding may be misdirected
2/18/2011
Lack of specifics from FDA begets confusion
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Vetsulin’s removal from market could be temporary
2/8/2011
Intervet ceases production due to bacterial contamination concerns
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Price soars on popular antibiotic metronidazole
1/13/2011
Limited competition among manufacturers behind increase
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AVMA cautions DEA on plans to raise propofol to controlled status
12/22/2010
Comment period closes Dec. 27
-
Target tests market for pet medications
12/22/2010
Trend in retail sales of veterinary drugs accelerating
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Veterinarians scramble for mainstay chemotherapy drug
12/20/2010
Doxorubicin hydrochloride in short supply
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FDA releases government data on antibiotic use in food animals
12/9/2010
Non-therapeutic quantities not specified, leaving key questions unanswered
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Veterinarian struggles to protect her online reputation
12/8/2010
Practitioner suspects Internet extortion is at play
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DEA wants propofol elevated to scheduled status
11/10/2010
Change likely to impact veterinary practices
-
PetMed Express reports slip in sales
10/19/2010
Ad costs rise as consumer spending falls with the online pharmacy
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Comments sought on EPA unused-drug disposal recommendations
10/15/2010
Agency skips medical facilities survey, directly drafts guidelines
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Lawsuit raises questions about sale of drugs to non-veterinarian
10/13/2010
Case brought by Bayer against shelter rescheduled for Dec. 2 hearing
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Accidental hormone exposures prompt proposed drug label changes
10/11/2010
Seller of topical hormone Evamist awaiting FDA review
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VIN unveils recall center for veterinarians, consumers
9/27/2010
Site intended to act as information resource
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Scrutiny of secondary topical hormone exposures deepens
9/9/2010
Veterinarians to be surveyed; FDA fields reports involving pets and children
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Supplies of injectable butorphanol tartrate to normalize, veterinary insiders report
9/3/2010
Pfizer Animal Health assures commitment to manufacture Torbugesic
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CEVA buys Summit VetPharm
9/2/2010
Plans to market Vectra parasiticides globally
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Propofol shortage hits veterinary medicine
8/26/2010
Clinics turn to alternatives with production of PropoFlo, Rapinovet stopped
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IV furosemide vanishing from veterinary market
8/12/2010
Medication on back order for months, distributors say
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FDA investigating accidental hormone exposure problem
7/29/2010
Issues safety alert on topical estrogen spray product Evamist
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Hormone replacement skin products affect users’ pets, confound veterinarians
6/10/2010
Symptoms include swollen vulvas, enlarged mammaries, fur loss
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Franck’s Pharmacy negotiates with FDA in Washington on veterinary compounding
5/20/2010
Outcome could have broad effects on industry, some contend
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Bayer wins some, loses some
4/28/2010
New sales policy continues to reverberate
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FDA calls veterinary compounding at Franck’s illegal
4/19/2010
In unprecedented action, agency seeks court injunction against pharmacy
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Heartworm treatment drug remains in short supply
4/15/2010
FDA must approve manufacturing facility, Merial reports
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Brand-name buprenorphine production up
4/14/2010
Extended shortage has had veterinarians scrambling
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Mexiletine hydrochloride is back in 150-mg capsules
4/9/2010
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U.S. EPA confirms problems exist with spot-on flea, tick treatments
3/18/2010
Agency proposes changes in labeling, safety monitoring
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Merial details company stance on product diversion
2/26/2010
Executives speak out after veterinarians question company loyalty
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New feline thyroid drug raises safe-handling questions
2/1/2010
Experts say warnings apply to all forms of methimazole
-
Seven labels tied to Teva ketamine recall, FDA says
12/31/2009
Details from FDA could alleviate confusion for practitioners
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Expanded ketamine recall leaves veterinarians with unanswered questions
12/29/2009
Action culminates rocky year for Teva Animal Health
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2009 brought huge consolidations in animal health industry
12/21/2009
Butler and Schein merger latest in a series
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Drug maker sues compounding pharmacy
12/17/2009
Bayer says Wedgewood infringing on patent
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Merial reports Immiticide, Heartgard shortages
12/5/2009
Rationing of Immiticide leaves some veterinarians in a lurch
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Confounding Compounding
11/24/2009
Growth of pharmacy practice fuels worries about quality, future
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Company short on Vetsulin details, veterinarians long on frustration
11/9/2009
Practitioners confused, asking questions about stability concerns following FDA's warning
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BI reportedly stops U.S. sales of Mexitil, sparking concern from veterinarians
10/8/2009
Teva Pharmaceuticals USA might be nation’s only maker of mexiletine hydrochloride
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Dog stuck in crate highlights rare risk of spot-on flea treatment
10/7/2009
Benzyl alcohol acted like glue, sticking pet to plastic
-
Virbac recalls Iverhart Plus
8/20/2009
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Propofol recall expanded
8/4/2009
Three additional lots affected
-
Teva Animal Health closes shop
8/3/2009
FDA shuts down plant, sparks product availability concerns
-
Sanofi makes $4-billion deal with Merck for Merial
7/31/2009
Ultimate plan could create world's largest animal-health company
-
Tainted lots of propofol prompt recall
7/15/2009
CDC, FDA urge clinicians to check inventory
-
Researchers study duration of immunity for rabies vaccines
6/18/2009
Public supports work with $400,000 in donations
-
FDA denies Nutro investigation despite reports indicating otherwise
4/27/2009
News outlets retract stories that link pet food to adverse reactions, including death
-
Makers of spot-on products summoned for EPA meeting
4/24/2009
Oregon State University is taking adverse reaction reports from veterinarians
-
EPA investigates reactions from flea, tick killers
4/17/2009
Agency is scrutinizing products' safety
-
HSUS to take Prop 2-like action to Ohio
4/6/2009
Veterinarians gear up for talks to thwart high-stakes conflict with activists
-
The flea market
4/6/2009
Exploring the diversion of parasiticides from manufacturers, veterinary offices to Web sites, store shelves
-
Merck buys Schering-Plough
3/11/2009
-
Blockbuster Pfizer-Wyeth deal stirs veterinary medicine
2/9/2009
Merger muddies outlook for Fort Dodge Animal Health
-
About-face by Florida regulators eases permit policy for DVMs
1/14/2009
Refunds are on the agenda, FVMA says
-
Treatment for Cushing's syndrome to hit market
12/17/2008
FDA approves trilostane for canine patients
-
VetCentric Executive Admits Accounts Irk Many
11/23/2008
VetCentric gives veterinarians a hard pill to swallow while altering business model in response to authorities ruling their original business model a kick back for writing prescription.
-
Glycopyrrolate shortage?
10/17/2008
It's still in stock, distributors say
-
FDA alerts veterinarians to new ivermectin directions
9/10/2008
Merial changes instructions for Eqvalan Liquid for Horses
-
EPA survey: How do you dispose of unused pharmaceuticals?
8/29/2008
Agency wants to know why some still dump drugs down the drain
-
Theophylline production held up by FDA, manufacturer says
8/11/2008
Drug remains available in 100mg, 200mg tablets
-
Veterinarians face atropine shortage?
8/1/2008
Penn Veterinary Supply says it has the drug in stock despite backorder claims
-
15 drugs received approval in 2007, FDA reports
7/23/2008
Slentrol, Vetmedin, Cerenia rank among what agency officials characterize as "new therapeutic advances"
-
Drug makers agree to ethical code for doctor-company relationships
7/15/2008
Veterinary medicine might be next, insiders say
-
FDA approves antimicrobial for aquaculture uses
7/11/2008
Supplemental OK involves Terramycin 200
-
UPDATE: FDA bans cephalosporin drugs in food animals
7/3/2008
Federal regulators issue change amid concerns about antimicrobial resistance
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FDA chastises company, prompts plant shutdown
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February 1, 2012
By: Jennifer Fiala
For The VIN News Service
 Novartis Animal Health wants veterinarians to closely examine the Clomicalm on their shelves. In a letter to practitioners, Novartis warned that tablet mixups might have affected as many as 20 lots of the anti-anxiety medication.
As Novartis Animal Health warns veterinarians that incorrect tablets may be found in bottles of the anti-anxiety medication Clomicalm, highly critical reports from the U.S. Food and Drug Administration (FDA) reveal that manufacturing mishaps and failures to followup on consumer complaints are behind the temporary shutdown of the company's plant in Lincoln, Neb.
The plant's closure caused Novartis to suspend production of the antiparasitics Interceptor and Sentinel in December. Now a "Dear Doctor" letter is alerting practitioners to the “rare possibility” they might find a product mix-up affecting 20 lots of Clomicalm (clomipramine hydrochloride).
Novartis doesn't reveal exactly what might be mixed with Clomicalm, if anything. Joseph Burkett, head of global communications for the company's animal health division, did not return phone calls or emails from the VIN News Service seeking more information.
The Jan. 25 letter follows a recall that Novartis Consumer Health issued on Jan. 8, warning consumers that chipped or broken pills might be found in over-the-counter drugs such as Bufferin, Excedrin, Gas-X Prevention and NoDoz.
All of these products — animal- and human-health medications — are manufactured in the same Lincoln, Neb., facility.
To be sure the Dear Doctor letter reaches its target audience, Novartis wants veterinarians to return a response card that accompanies it. The company advises veterinarians to closely examine their bottles of Clomicalm for broken, off-color or unusually shaped tablets. Generally, Clomicalm tablets are oblong and speckled brown. Practitioners also are being asked to post the Novartis letter in their clinics and distribute copies of a "Dear Valued Customer" letter authored by Novartis on the topic.
Any abnormal findings should be reported to Novartis Animal Health at (800) 637-0281. Press 5 for a product defect technician.
Initially, Novartis officials told the VIN News Service that production of Interceptor and Sentinel might resume mid-January. In a vague statement, "process and compliance improvement activities" were blamed for the plant shutdown in December, and officials rebuffed questions about whether the FDA was involved in the decision.
It's now clear that FDA played a major role in the plant's closure. Inspection reports released by the FDA reveal that problems with the manufacturing facility and its operators were serious, with repeated warnings from the regulatory agency about quality control problems.
According to FDA investigators, consumers had complained about tablet mix-ups, foreign objects found in containers and the suspected tampering of bottles of Novartis drugs. In one reported instance, Novartis failed to investigate a complaint that a bottle of Excedrin Migraine tablets contained caplets. Another case involved a specific lot of Excedrin Extra Strength caplets mixed with Excedrin ES gelcaps. Partial or incomplete tablets found in a lot of Bufferin RS prompted 80 consumer complaints, the FDA noted in a Jan. 20 inspection report, yet Novartis closed its complaint investigation without addressing it. The FDA report refers to nearly 1,400 consumer complaints that Novartis neglected to respond to or forward to regulators.
"Your firm was aware of partial/incomplete Bufferin tablets/capsules issues since at least 2009, yet a Medical Safety Assessment Report was not released until 10/14/11. There is no justification or explanation for the approximately two-year delay in obtaining this report," the FDA wrote to the company following a four-week inspection that started mid-December.
The FDA also cited in its report that Novartis failed to identify how a dozen extra pills ended up in a sealed bottle of morphine sulfate, which a pharmacist reported finding last November. "There are no documented preventative measures within the investigation to ensure this type of problem does not continue," the FDA noted. "This is important because this consumer complaint was recently closed and is indicative of how your firm is currently investigating consumer complaints."
The FDA's scathing remarks continued in the 24-page report to identify human errors, sloppy procedures and improperly trained employees as root causes of problems at the Novartis plant.
The agency ordered Novartis to shutdown production in the plant on Dec. 11, eight days before the company alerted the public to its closure.
In a Jan. 25 filing with the U.S. Securities and Exchange Commission (SEC), Novartis stated that the "unexpected" closure of its plant in Lincoln, Neb., so far has cost the company $200 million — $115 million in costs directly tied to the plant's closure and $85 million in lost profits.
As for the company's animal health medications, Interceptor and Sentinel included, it's unclear when those drugs will be back in production.
"We plan to gradually resume operations at the Lincoln site following implementation of planned improvements and in agreement with the FDA," Novartis said in the filing. "However, as of the date of this Form 20-F, it is not possible to determine when the plant will resume full operations. The Lincoln facility produces a variety of products with annual sales of less then two percent of Novartis group sales.
"Should we fail to complete the planned improvements at the site in agreement with the FDA in a timely manner, then we may suffer a significant loss in sales," the company added.
Update: After consulting with the FDA, Novartis plans to make available to U.S. and Canadian veterinarians, stocked animal health inventory that was manufactured before the company's Lincoln, Neb., plant shut down December. According to a newly released Novartis statement, those products include Interceptor Flavor Tabs; Sentinel Flavor Tabs; Clomicalm; Program tablets and suspension; and Milbemite.
VIN News Service commentaries are opinion pieces presenting insights, personal experiences and/or perspectives on topical issues by members of the veterinary community. To submit a commentary for consideration, email news@vin.com.
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