FDA Grants Appeal to Recro Pharma for IV Meloxicam New Drug Application
Recro Pharma, Inc. (REPH)
Last recro pharma, inc. earnings: 11/8 07:00 am
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Source: GlobeNewswire
Received Positive Response from FDA Regarding IV Meloxicam Formal Dispute Resolution Request Company Remains on Track to Execute Spin Out of Acute Care Business Segment During the Fourth Quarter of 2019 MALVERN, Pa., Oct. 31, 2019 (GLOBE NEWSWIRE) -- Recro Pharma, Inc. (NASDAQ:REPH), a specialty pharmaceutical company with a high-performing revenue generating contract development and manufacturing (CDMO) division, today announced that it has received a written decision from the U.S. Food and Drug Administration (FDA) granting its appeal of the Complete Response Letter relating to the New Drug Application (NDA) seeking approval for intravenous (IV) meloxicam. The FDA’s letter states that the appeal was granted “specific to the request…that the NDA provides sufficient evidence of effectiveness and safety to support approval.” The letter also states that “before IV meloxicam can be approved and legally marketed, agreed-upon labeling (prescribing information) must be negotiate
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