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.
Novartis’ Tasigna receives priority review from FDA
EAST HANOVER, N.J. The Food and Drug Administration will shorten its review time of a Novartis drug under investigation as a treatment for leukemia, Novartis said Friday.
The agency plans to give priority review to Tasigna (nilotinib) for the treatment of adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia, also known as Ph+ CML, in the disease’s chronic phase. The FDA grants priority review to drugs that it considers to offer major advances in treatment or to provide treatment where no adequate therapy exists, accelerating the standard review time from 10 months to six.
Novartis said that in clinical trials, Tasigna stopped Ph+ CML from progressing to more advanced stages in “significantly” more patients than did the standard of care, Gleevec (imatinib mesylate), also made by Novartis.
“Recently presented data showed that Tasigna surpassed Gleevec in every measure of treatment efficacy designated in the study, including prevention of disease progression at 12 months,” Novartis Pharmaceuticals Division CEO David Epstein said. “Now, this priority review designation brings us one step closer to offering patients who are newly diagnosed with Ph+ CML in the chronic phase a promising new treatment option.”
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.”