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BRIEF-Therapeuticsmd provides TX-004HR regulatory update
2017年4月10日 / 下午12点31分 / 7 个月前

BRIEF-Therapeuticsmd provides TX-004HR regulatory update

April 10 (Reuters) - Therapeuticsmd Inc

* 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 Source text for Eikon: Further company coverage:

我们的标准:汤森路透“信任原则”
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