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.
For comments and feedback contact: editorial@rttnews.com
Business News
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.