FDA update for brand drugs for June 24, 2010

[chantell.reagan]

Dulera (mometasone/formoterol) by Merck Schering-Plough
Approval: maintenance treatment of asthma in patients 12 years of age and older

•Link to news article 6/10

Jevtana (cabazitaxel injection) by sanofi-aventis
Approval: in combination with prednisone for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen

•Link to FDA letter 6/10
•Link to prescribing information

Staxyn (vardenafil orally disintegrating tablets) by Bayer
Approval: treatment of erectile dysfunction

•Link to FDA letter 6/10

New dosage forms:
Namenda XR (memantine extended-release capsules) by Forest
Approval: treatment of moderate to severe dementia of the Alzheimer’s type.

•Link to Forest press release 6/10
•Link to prescribing information

Expanded indications:
Tasigna (nilotinib capsules) by Novartis
Approval: treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase

•Link to FDA letter 6/10
•Link to prescribing information

Lucentis (ranibizumab injection) by Genentech
Approval: treatment of macular edema following retinal vein occlusion (RVO); FDA approved this new indication after a 6 mo priority review

•Link to Genentech press release 6/10

Sources:
U.S. Food and Drug Administration. Drugs@FDA. Available at: Drugs@FDA
U.S. Food and Drug Administration. Center for Biologics Evaluation and Research. Available at: CBER