April 10, 2007
Product news from the 04/10/07 news brief
The FDA announced the approval of the Cangene Corporation’s HepaGam B for the prevention of hepatitis B reinfection in certain liver transplant patients. HepaGam B is the first product of its kind (an immune globulin product) approved for this purpose.
The FDA has approved Abbott's new coated Niaspan (niacin extended-release tablets).
Barr Laboratories has initiated a patent challenge for Sanofi-Aventis’ Ambien CR (Zolpidem Tartrate Extended-Release Tablets), 6.25 mg and 12.5 mg. Barr has filed its Abbreviated New Drug Application containing a paragraph IV certification for a generic Ambien CR product with the FDA in December 2006. On April 5, Sanofi-Aventis filed suit in the US District Court of New Jersey to prevent Barr from proceeding with commercialization of its product.
Wyeth announced that the FDA has extended the review of the New Drug Application (NDA) for Torisel (temsirolimus), Wyeth’s investigational treatment for advanced renal cell carcinoma. The NDA for Torisel originally was submitted on Oct. 5, 2006, and was granted priority review status. As part of the ongoing review, Wyeth recently submitted additional information on tumor evaluation, as requested by the FDA. On April 5, the FDA confirmed that as a result of this amendment, the action date for the NDA has been extended by three months, to July 2007, to allow the agency time to complete a full review of these analyses.