Depomed, Inc. (DEPO) said Friday that the U.S. Food and Drug Administration has declined to approve Sefelsa, the company's investigational, oral, twice daily formulation of gabapentin to treat moderate to severe vasomotor symptoms due to menopause.
In its complete response letter, the FDA said it cannot approve the New Drug Application for Sefelsa in its present form.
Based on the letter, Depomed said it does not currently plan to further invest in Sefelsa.
"The CRL was expected in light of the SEFELSA FDA Advisory Committee meeting," said Jim Schoeneck, President and Chief Executive Officer.
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