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Jun 10, 2013
 |  BC Week In Review  |  Clinical News  |  Regulatory

Sefelsa gabapentin GR regulatory update

Depomed does not "intend to further invest" in Sefelsa gabapentin after FDA issued a complete response letter for an NDA for the product to treat moderate to severe vasomotor symptoms associated with menopause. According to Depomed, the letter said the agency cannot approve the application in its present form. The company could not be...

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