Recro Pharma (REPH) Announces CRL from FDA for IV meloxicam NDA
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Recro Pharma Receives Complete Response Letter from the FDA
May 24, 2018 7:00 AM EDTMALVERN, Penn., May 24, 2018 (GLOBE NEWSWIRE) -- Recro Pharma, Inc. (Nasdaq: REPH), a revenue generating specialty pharmaceutical company focused on therapeutics for the hospital and other acute care settings, today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) Office of Drug Evaluation II regarding the New Drug Application (NDA) for IV meloxicam.
The CRL stated that although the outcome of the pivotal phase III trials demonstrated statistically significant outcomes on the primary endpoints, the FDA is unable to approve the... More
