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surf1944

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surf1944

Re: surf1944 post# 297

Monday, 06/03/2013 9:38:25 AM

Monday, June 03, 2013 9:38:25 AM

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1:23AM DepoMed FDA issues Complete Response Letter on SEFELSA New Drug Application (DEPO) 5.76 : Co announces that the FDA issued a complete response letter to the New Drug Application for SEFELSA, Depomed's investigational, oral, twice daily formulation of gabapentin to treat moderate to severe vasomotor symptoms due to menopause. The CRL states that the FDA cannot approve the application in its present form. Based on the letter, Depomed does not currently intend to further invest in SEFELSA.

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