Theophylline production held up by FDA, manufacturer says

Drug remains available in 100mg, 200mg tablets

August 11, 2008 (published)
By Jennifer Fiala

Inwood, N.Y. — Bureaucratic red tape has slowed Inwood Laboratory's distribution of theophylline. The drug is not being discontinued, officials with the manufacturer say.

The company stopped distributing 300mg tablets to veterinarians while it awaits the Food and Drug Administration's (FDA) final approval of its new production facility, Inwood spokeswoman Loraine Perotta says. Inwood, which moved its manufacturing plant from New York to Ohio in November, says the facility passed FDA inspection in February, but agency officials wanted more information, which the company provided.

"We have theophylline all packaged and ready to go; we're just waiting on FDA," Perotta says. "They said something was wrong with their computer system, and now they say there's a backlog with other company inspections. It's a terrible situation."

Phone calls seeking comment from FDA were not immediately returned.

In the meantime, 100mg and 200mg tablets remain available to DVMs. Inwood expects to resume distribution of 300mg tablets within the next few months, Perotta says. 

More information about the Inwood brand of theophylline can be found in the VIN Medical FAQ. The drug is a phosphodiesterase inhibitor that dilates the airways and mainly is used in patients with chronic bronchitis, asthma or tracheal collapse. The Inwood brand is the only version that shows suitable pharmacokinetics for canine patients and, therefore, is the only one recommended for use by VIN Consultants.

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