Drugs

Norwich Loses Generic Rifaximin Case

The DC federal court has rejected Norwich Pharmaceuticals’ request for summary judgment in a case seeking FDA final approval of its ANDA for rifaximin tablets. Instead, the court granted summary judgment to FDA and also to Teva and Salix, who intervened in the proceedings as defendants. Salix owns the branded version of rifaximin tablets that Norwich cited as the reference-listed drug, and Teva is the parent company of Actavis Laboratories, to which FDA granted 180-day marketing exclusivity as the first firm to file an ANDA for rifaximin.

DC federal judge Beryl Howell expressed understanding for Norwich’s frustration over the 10-year lapse between Actavis’ submission of its ANDA and FDA’s still-outstanding grant of temporary approval for the Norwich submission. Norwich asserted that Actavis lost its right to exclusivity for failing to market its generic version of rifaximin.

Howell noted that Actavis’ drug will be coming to market almost two years earlier than it could have considering Salix’ last expiring patent, and also said that litigation between Salix and Norwich is ongoing to determine whether the Norwich ANDA infringes on Salix’ patents.

Further, she said, Congress included in the Hatch-Waxman Act an express exception to forfeiture of exclusivity for delays in tentative approval caused by changes in approval requirements, such as in the 2003 Medicare Modernization Act, beyond an ANDA applicant’s control. She said the solution to Norwich’s issues lies with Congress and not with the courts.

“The only dispute,” Howell concluded, “is whether FDA erred in finding that Actavis has not forfeited its 180-day marketing exclusivity. Norwich argues that Actavis has forfeited its 180-day exclusivity by failing to market and failing to obtain tentative approval. Contrary to the, at times, convoluted arguments put forward by Norwich, FDA’s decision comports with the clear text and structure of the statute.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome