FDA gives Barr final approval for generic Kytril
MONTVALE, N.J. Barr Laboratories has received final approval from the Food and Drug Administration for its generic version of Kytril, by Roche Laboratories. Kytril is used to prevent nausea and vomiting associated with initial and repeated courses of chemotherapy as well as radiation.
The generic, granisetron hydrochloride, will be available in 1 mg tablets. Barr received final approval for the drug following the expiration of Roche’s patent on Dec. 28. The company plans to launch it immediately.
Kytril had annual sales of about $88 million for the 12 months that ended October 2007, according to IMS sales data.
Orion, Sun in patent fight over Stalevo
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’.
Forest, Cypress submit application to FDA for fibromyalgia treatment
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.