Mylan denied preliminary injunction against GSK, Apotex
PITTSBURGH A U.S. District Court denied a motion for a preliminary injunction filed by Mylan to prevent Canadian generic drug maker Apotex from making a generic version of an extended-release antidepressant drug, Mylan said Monday.
Mylan said the U.S. District Court for the District of New Jersey erred in its decision, and it intends to appeal.
Last month, Mylan obtained a temporary restraining order from the court preventing Apotex from selling a generic version of GlaxoSmithKline’s antidepressant Paxil CR (paroxetine hydrochloride). The order also prevented GSK from supplying generic versions of the drug to Apotex.
Teva, Sandoz launch Prevacid SoluTab generics
JERUSALEM The Food and Drug Administration granted approval for Teva’s abbreviated new drug application to market a generic version of a drug designed to treat peptic ulcers.
The generic drug maker said that its drug, lansoprazole, is a generic version of Takeda’s Prevacid SoluTab. Annual sales of the branded product were approximately $453 million in the United States, according to IMS sales data.
Sandoz, the generics division of Swiss drug maker Novartis, also announced the launch of its own version of Prevacid SoluTab.
FDA OKs expanded use of Baraclude
PRINCETON, N.J. The Food and Drug Administration has approved an additional use for a hepatitis drug.
Bristol-Myers Squibb announced Monday the approval of Baraclude (entecavir) as a treatment for chronic hepatitis B in adults with decompensated liver disease. The drug already is approved for adults with evidence of active viral replication.
“This additional indication for Baraclude is important news as it is now proven to be an effective treatment option for physicians to help in managing chronic hepatitis B patients with decompensated liver disease,” University of Hawaii professor of medicine Naoky Tsai said.