May 24, 2018 / 11:25 AM / 4 months ago

BRIEF-Recro Pharma Receives Complete Response Letter From FDA

May 24 (Reuters) - Recro Pharma Inc:

* RECRO PHARMA RECEIVES COMPLETE RESPONSE LETTER FROM THE FDA

* RECRO PHARMA INC - RECEIVED CRL FROM FDA REGARDING NEW DRUG APPLICATION FOR IV MELOXICAM

* RECRO PHARMA INC - RECEIVED CRL FROM FDA OFFICE OF DRUG EVALUATION II REGARDING NEW DRUG APPLICATION (NDA) FOR IV MELOXICAM

* RECRO PHARMA INC - CRL STATES DATA FROM AD HOC ANALYSES & SELECTIVE SECONDARY ENDPOINTS SUGGEST ANALGESIC EFFECT DOES NOT MEET EXPECTATIONS OF FDA

* RECRO PHARMA INC - CRL RAISED CMC RELATED QUESTIONS ON EXTRACTABLE AND LEACHABLE DATA PROVIDED IN NDA

* RECRO - CRL STATED ALTHOUGH OUTCOME OF PIVOTAL PHASE III TRIALS WERE STATISTICALLY SIGNIFICANT, FDA UNABLE TO APPROVE APPLICATION IN CURRENT FORM

* RECRO PHARMA INC - INTEND TO REQUEST A MEETING WITH FDA AS SOON AS POSSIBLE TO DISCUSS POINTS RAISED IN CRL Source text for Eikon: Further company coverage:

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