Monday, January 14, 2013
Reproductive Health Drugs Advisory Committee Meeting
Reproductive Health Drugs Advisory Committee Meeting
Committee Meeting March 4, 2013 8:00 a.m. to 5:00 p.m.
Agenda : On March 4, 2013, during the morning session, the committee will discuss new drug application (NDA) 022506, gabapentin 600 milligram (mg) tablets, submitted by Depomed, Inc., for the proposed indication of treatment of moderate to severe vasomotor symptoms due to menopause.
During the afternoon session, the committee will discuss NDA 204516, paroxetine mesylate 7.5 mg capsules, submitted by Noven Therapeutics, LLC, for the proposed indication of treatment of moderate to severe vasomotor symptoms associated with menopa
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