PHARMACY

Watson CEO to serve as GPhA chairman

BY Alaric DeArment

NAPLES, Fla. Watson Pharmaceuticals president and CEO Paul Bisaro will serve as the Generic Pharmaceutical Association’s chairman for 2010-2011, GPhA announced.

Bisaro has led Watson since 2007, after a stint as president and CEO of Barr Labs that began in 1999. He has served on GPhA’s board of directors since 2008, most recently as vice chairman.

“Paul will provide us with a steady hand as GPhA next navigates the often turbulent issues of health reform and the nation’s economic recovery,” GPhA president and CEO Kathleen Jaeger said. “GPhA looks forward to working with him, our board of directors and executive committee in what will be a challenging year.”

The organization also elected Mylan Pharmaceutical president Tony Mauro as vice chairman, New Chemic senior consultant Rosendo Ferran as secretary-treasurer. Nycomed U.S. CEO Paul McGarty, Teva North America president and CEO William Marth, Sandoz president and CEO Christine Mundkur and Zydus Pharmaceuticals president and CEO Joe Renner will serve as at-large members on the board’s executive committee.

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PHARMACY

Watson seeks FDA approval for depression generic

BY Alaric DeArment

MORRISTOWN, N.J. Watson Pharmaceuticals has filed a regulatory approval application with the Food and Drug Administration for a generic drug to treat depression, the generic drug maker announced Monday.

Watson filed an application for bupropion hydrobromide tablets in the 174-mg and 348-mg strengths through its subsidiary, Watson Labs Inc.-Florida. The drug is a generic version of Biovail’s Aplenzin ER, used to treat major depressive disorder.

Because Watson filed its application prior to the expiration of Biovail’s patents, Biovail filed suit against Watson Thursday in the U.S. District Court for the District of Delaware. Under the Hatch-Waxman Act of 1984, the suit places a stay of final FDA approval on Watson’s version of the drug for up to 30 months or until the two companies resolve the matter before the court.

Watson said it may be the first company to file for approval of a generic version of Aplenzin, which would allow it to compete directly with the branded version of the drug for six months following patent expiration, which will occur in 2026, according to FDA records.

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Rituxan gets nod of approval from FDA

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration has approved a drug made by Roche subsidiary Genentech and Biogen Idec as a treatment for the most common type of adult leukemia, the agency announced Thursday.

The FDA approved Rituxan (rituximab) for patients with chronic lymphocytic leukemia who are beginning chemotherapy for the first time and for those who have not responded to other CLL drugs. The drug is already used to treat non-Hodgkin’s lymphoma and rheumatoid arthritis and is the third drug to win FDA approval as a treatment for CLL, after the October 2009 approval of GlaxoSmithKline’s and Genmab’s Arzerra (ofatumumab) and the March 2008 approval of Cephalon’s Treanda (bendamustine hydrochloride).

“Rituxan with chemotherapy can delay the need for additional treatment because it significantly extends the time people with CLL live without the disease worsening,” Roche and Genentech EVP global development and chief medical officer Hal Barron said in a statement. “This approval provides an important option and new hope to the many people with this incurable cancer.”

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