Report: FDA to speed up generic drug approval process
NAPLES, Fla. The Food and Drug Administration hopes to accelerate the review process for generic drugs, according to published reports.
In the face of a growing backlog of generic drug applications –– a number that increased from 515 in 2003 to 1,500 in 2008 –– FDA commissioner Margaret Hamburg said at the Generic Pharmaceutical Association’s annual meeting in Naples, Fla., that she would seek to implement a system of application fees to address funding shortages, the New York Times reported.
The FDA submitted its budget request to the Obama administration at the beginning of the month, requesting $51.5 million for the Office of Generic Drugs, $10 million more than it got last year.
Watson seeks FDA approval for depression generic
MORRISTOWN, N.J. Watson Pharmaceuticals has filed a regulatory approval application with the Food and Drug Administration for a generic drug to treat depression, the generic drug maker announced Monday.
Watson filed an application for bupropion hydrobromide tablets in the 174-mg and 348-mg strengths through its subsidiary, Watson Labs Inc.-Florida. The drug is a generic version of Biovail’s Aplenzin ER, used to treat major depressive disorder.
Because Watson filed its application prior to the expiration of Biovail’s patents, Biovail filed suit against Watson Thursday in the U.S. District Court for the District of Delaware. Under the Hatch-Waxman Act of 1984, the suit places a stay of final FDA approval on Watson’s version of the drug for up to 30 months or until the two companies resolve the matter before the court.
Watson said it may be the first company to file for approval of a generic version of Aplenzin, which would allow it to compete directly with the branded version of the drug for six months following patent expiration, which will occur in 2026, according to FDA records.
Rituxan gets nod of approval from FDA
ROCKVILLE, Md. The Food and Drug Administration has approved a drug made by Roche subsidiary Genentech and Biogen Idec as a treatment for the most common type of adult leukemia, the agency announced Thursday.
The FDA approved Rituxan (rituximab) for patients with chronic lymphocytic leukemia who are beginning chemotherapy for the first time and for those who have not responded to other CLL drugs. The drug is already used to treat non-Hodgkin’s lymphoma and rheumatoid arthritis and is the third drug to win FDA approval as a treatment for CLL, after the October 2009 approval of GlaxoSmithKline’s and Genmab’s Arzerra (ofatumumab) and the March 2008 approval of Cephalon’s Treanda (bendamustine hydrochloride).
“Rituxan with chemotherapy can delay the need for additional treatment because it significantly extends the time people with CLL live without the disease worsening,” Roche and Genentech EVP global development and chief medical officer Hal Barron said in a statement. “This approval provides an important option and new hope to the many people with this incurable cancer.”