FDA approves Actavis’ generic Ambien CR
MORRISTOWN, N.J. The Food and Drug Administration has approved a drug for treating insomnia made by Actavis, the generic drug maker said Monday.
Actavis announced the approval of zolpidem tartrate extended-release tablets in the 6.25-mg strength. The company has begun shipping the drug.
The drug is a generic version of Sanofi-Aventis’ Ambien CR, which had sales of around $129 million during the 12-month period ended in June, according to IMS Health.
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.