Sefelsa Development Halted after FDA Issues Complete Response Letter
Depomed Inc. announced that the FDA has issued a Complete Response Letter to the New Drug Application (NDA) for Sefelsa, an investigational, oral, twice daily formulation of gabapentin for the treatment of moderate to severe vasomotor symptoms due to menopause.
The Complete Response Letter states that the FDA cannot approve the application in its present form. Currently Depomed does not intend to further invest in Sefelsa, formerly known as Serada based on the letter it has received.
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