Sciele receives FDA approval for four Sular dosages
ATLANTA Sciele Pharma has received approval from the Food and Drug Administration for all four dosage strengths of the formulation for the company’s drug Sular.
Sular is used for the treatment of hypertension either along or in combination with other antihypertensive agents. The drug is available in 10, 20, 30 and 40 mg strengths. The new formulation of the drug uses SkyePharma’s geomatrix technology, which provides a lower dose of Sular for each of its current doses.
Therapy usually should be initiated with 20 mg orally once daily, then increased by 10 mg per week or longer intervals, to attain adequate control of blood pressure.
The company expects to launch the new formulation of the drug during the first quarter of 2008.
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.