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Replies to #297 on Depomed (DEPO)
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surf1944

06/03/13 9:38 AM

#301 RE: surf1944 #297

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.