FDA gives tentative approval to Mylan’s Topamax generic
WASHINGTON Mylan Pharmaceuticals has received tentative approval from the Food and Drug Administration for its application for Topiramate capsules.
Topiramate capsules are the generic version of Ortho McNeil Pharmaceuticals Topamax sprinkle capsules. The new generic will be available in 15 and 25 mgs. The drug had sales of approximately $46 million in the U.S. for the 12 months ending June 30, 2007.
Topamax is used as a mood stabilizer for people with bipolar disorder.
Teva announces shipment of generic Famvir
Teva Pharmaceutical Industries Ltd. has begun the shipment of its generic version of Novartis’ Famvir herpes treatment, the company said Friday.
As the first drug developer to file for a generic version of the drug, famciclovir, Teva has been awarded a 180-day period of marketing exclusivity.
The announcement comes two days following the U.S. District Court in New Jersey’s decision to deny Novartis’ motion for a preliminary injunction, which would have prevented Teva from marketing its version of Famvir.
During afternoon trading, shares of the Israeli company fell 11 cents to $43.39, while Novartis’ American Depositary Shares rose 8 cents to $53.41.
In 2006, Famvir net sales totaled at $166 million in the United States.
Actavis’ generic Norvasc gets approval from FDA
NEW YORK The Food and Drug Administration approved Actavis Group’s generic version of a well-known high blood pressure medication, the company announced Friday.
The company said they were given the go-ahead to develop amlodipine besylate tablets, the generic form of Pfizer’s Norvasc. The medication will be available in 2.5, 5 and 10 mg doses.
Actavis, one of the leading generic pharmaceutical companies in the world, operates in close to 40 countries, and continues to expand its business with various product developments. The company became privately owned last month.
In the interim, shares of Pfizer fell 7 cents to $24.55 in morning trading.