Depomed, Inc. (Nasdaq: DEPO), a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) 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.
"The CRL was expected in light of the SEFELSA FDA Advisory Committee meeting," said Jim Schoeneck , President and Chief Executive Officer. "Depomed today is a product-focused, growth-oriented specialty pharmaceutical company with revenues from two marketed products, Gralise and Zipsor, significant royalty income from our partnered products and technology, a strong balance sheet and potential to turn cash flow positive in the second half of this year."
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