PHARMACY

Watson to begin distribution of generic Biaxin

BY Drew Buono

CORONA, Calif. Watson Pharmaceuticals has begun launching its new product, a generic form of Abbott’s antibiotic Biaxin XL. The drug is indicated to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

The generic, clarithromycin extended-release, will be available in a 500 mg tablet strength. The patent infringement case impeding Watson from launching the generic was dismissed on July 12.

For the 12-months ending September 2007, Biaxin XL and its generic equivalents had total U.S. sales of approximately $200 million, according to IMS Health data.

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PHARMACY

Orion, Sun in patent fight over Stalevo

BY Drew Buono

HELSINKI, Finland Orion has extended a patent suit against Sun Pharmaceuticals, which is challenging the company on its Parkinson’s disease treatment drug Stalevo, according to published reports.

Orion is already suing Sun to prevent it from making a generic version of the drug, which is generically called carbidopa/levodopa. Sun has now amended its application to contain Paragraph IV challenges against three of Orion’s patents covering Stalevo.

The challenges mean Sun is either claiming Orion’s patents are invalid or that it would not be infringing on Orion’s patent rights by making a generic version.

Orion, which is evaluating its legal options together with Novartis, the company which exclusively markets Stalevo in the, said the application review process has only just begun and that generic competition is ‘neither certain nor imminent’.

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Forest, Cypress submit application to FDA for fibromyalgia treatment

BY Drew Buono

NEW YORK and SAN DIEGO Forest Laboratories and Cypress Bioscience have recently submitted a drug application to the Food and Drug Administration for milnacipran, a drug for treatment of fibromyalgia syndrome, according to published reports.

The submission includes efficacy data from two Phase III trials involving 2,084 patients, which showed that milnacipran demonstrated improvement compared to a placebo in treating fibromyalgia, the companies said.

Currently, only Pfizer’s Lyrica is approved in the U.S. to treat fibromyalgia, which affects up to 6 million Americans.

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