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BRIEF-TherapeuticsMD receives complete response letter from FDA for TX-004hr NDA
2017年5月8日 / 中午12点12分 / 6 个月前

BRIEF-TherapeuticsMD receives complete response letter from FDA for TX-004hr NDA

May 8 (Reuters) - Therapeuticsmd Inc

* Therapeuticsmd receives complete response letter from fda for tx-004hr new drug application

* Therapeuticsmd inc - no approvability issues identified by fda related to efficacy or cmc

* Therapeuticsmd inc - crl did not identify any issues related to efficacy of tx-004hr

* Therapeuticsmd inc - no cases of endometrial hyperplasia were observed in rejoice trial at end of week 12 for all doses studied and included in nda

* Therapeuticsmd-Concern raised by fda was lack of long-term endometrial safety data for tx-004hr beyond 12-weeks studied in pivotal phase 3 rejoice trial

* Therapeuticsmd - crl did not identify issues related to efficacy of tx-004hr, did not identify approvability issues related to chemistry and controls

* Therapeuticsmd inc - co believes that nda was approvable as filed and intends to meet with fda as soon as possible to address concerns raised by fda

* Therapeuticsmd-Continuing to prepare nda for tx-001hr and anticipate that co will submit that nda to fda as early as q3 of 2017 Source text for Eikon: Further company coverage:

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