(Adds details, shares)
May 8 Women's healthcare company TherapeuticsMD Inc said the U.S. Food and Drug Administration had rejected its application to market its drug to treat vaginal pain, sending its shares down about 13 percent in premarket trading on Monday.
The FDA had identified issues related to long-term safety data, the company said.
"We... respectfully disagree with the FDA's decision," TherapeuticsMD's Chief Executive Robert Finizio said, adding that there are multiple paths forward to address the concerns.
The drug, TX-004HR, is being developed to treat moderate-to-severe vaginal pain during sexual intercourse in post-menopausal women.
Last month, the company said it received a letter from the FDA identifying deficiencies in the drug's application, but did not mention them.
Shares of the Boca Raton, Florida-based company were down 13.3 percent at $4.05 before the bell. Up to Friday's close, the stock had fallen 41 percent in the last 12 months. (Reporting by Divya Grover in Bengaluru; Editing by Sai Sachin Ravikumar and Martina D'Couto)
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