Briefs: Depomed drops Sefelsa after CRL: Sun Pharma stalking Meda?

US specialty drugmaker Depomed (Nasdaq: DEPO) says that Food and Drug Administration issued a complete response letter (CRL) to the New Drug Application for Sefelsa, the firm's investigational, oral, twice daily formulation of gabapentin to treat moderate to severe vasomotor symptoms due to menopause.

The CRL - the second one issued for the drug - states that the FDA cannot approve the application in its present form. Based on the letter, Depomed says that it 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, "Depomed today is a product-focused, growth-oriented specialty pharmaceutical company with revenues from two marketed products, Gralise [gabapentin] and Zipsor [diclofenac potassium], 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."