Regulatory Focus™ > News Articles > FDA Ordered to Approve Watson Laboratories' ANDA for Generic Actos

FDA Ordered to Approve Watson Laboratories' ANDA for Generic Actos

Posted 23 October 2012 | By

The US Food and Drug Administration (FDA) has been ordered to immediately approve an abbreviated new drug application (ANDA) submitted to the agency by Watson Pharmaceuticals, marking what some analysts are calling a rare defeat for the agency's regulatory discretion.

The case, decided by US District Court of Washington, DC, Judge Amy Berman Jackson, regarded the diabetes medication Actos (pioglitazone), one of the most prescribed drugs in the US. Watson, a generics manufacturer, had been excluded from 180-days of marketing exclusivity granted to two other generic drug manufacturers, Teva and Mylan, Inc for Takeda's Actos.

Under the 1984 Hatch Waxman Act, FDA is supposed to give 180 days of market exclusivity to the first company to introduce a generic equivalent to a product with an expired patent. The intent is to get generic products to market faster by giving the companies a period during which to establish their business and operate without other generic competitors, allowing them to charge a premium for their products.

But companies may also negotiate for shared periods of exclusivity with the consent of a branded manufacturer, usually in return for settling litigation or for one-time cash payments or ongoing royalties.

A shared exclusivity agreement was struck between Watson, Teva and Mylan in 2010. However, in August 2012, according to Bloomberg, FDA denied Watson's ANDA while simultaneously approving Teva and Mylan's ANDA's for the same product.

Watson then filed suit, calling the actions, "Arbitrary, capricious and contrary to law."

Jackson agreed with the company's sentiments, and ordered FDA to, "approve Watson Laboratories' ANDA for generic pioglitazone effective immediately so that Watson Laboratories may participate in what remains of the shared exclusivity period previously awarded to other generic manufacturers of the drug."

The court's decision remains under seal for the time being due to the presence of confidential and sealed information.

Read more:

Bloomberg - Watson Can Sell Generic Actos Now, U.S. Judge Rules

The Pink Sheet Daily - Watson's Generic Actos To Get One-Third Of Shared Exclusivity; Court Orders FDA To Approve ANDA

Law 360 - Judge Orders FDA to Approve Watson's Generic Actos

DC District Court - Opinions

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