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Depomed, Inc.
DEPO, a
specialty pharmaceutical company, announced today that the Reproductive Health
Drugs Advisory Committee (RHDAC) of the U.S. Food and Drug Administration
(FDA) voted 2-12 against approval for SEFELSA, Depomed's investigational,
oral, twice daily formulation of gabapentin,^ to treat moderate to severe
vasomotor symptoms due to menopause. SEFELSA is the proposed trade name for
the medication and was formerly referred to as Serada. Based on the outcome
of committee meeting, the company will not have a conference call today as
previously indicated.
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