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TherapeuticsMD: FDA IDs deficiencies in review

April 10, 2017

*Therapeuticsmd provides tx-004hr regulatory update

* Therapeuticsmd Inc – on April 7, received a letter from fda

* Therapeuticsmd-FDA says as part of review of tx-004hr nda, has identified deficiencies preclude discussion of labeling, postmarketing requirements/at this time

* Therapeuticsmd inc – letter states that notification does not reflect a final decision on information under review

* Therapeuticsmd Inc – letter does not specify deficiencies identified by FDA and at this time company is not aware of nature of deficiencies

* Therapeuticsmd Inc – intends to work with fda to understand nature of deficiencies and resolve them as quickly as possible

http://reut.rs/2oqefSJ

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