The FDA had attributed its second CRL to the delayed onset of meloxicam, which failed to meet the prescriber expectations for IV drugs, according to Recro
Recro Pharma's shares dropped more than 50 percent on Thursday after the U
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This is the second CRL that Recro Pharma has received for intravenous (IV) meloxicam
REPH plunged 34% on Mar 25, following a complete response letter (“CRL”) to the new drug application (“NDA”) seeking approval
IV meloxicam was meant to be Recro’s first marketed product
Received Positive Response from FDA Regarding IV Meloxicam Formal Dispute Resolution RequestCompany Remains on Track to Execute Spin Out of Acute Recro Pharma Inc
(Nasdaq Recro intends to continue to pursue regulatory approval for IV meloxicam and will request a meeting with the FDA and work closely with them to resolve these issues
The FDA noted that a delayed onset does not meet prescriber expectations for intravenous drugs like meloxicam
(NASDAQ:REPH), a revenue generating specialty pharmaceutical company focused The FDA has once again put the brakes on Recro Pharma’s efforts to bring its pain killer meloxicam to market, the company has acknowledged
million within 180 days following approval of IV meloxicam by the FDA
In May, the FDA rejected the company's initial new drug application for IV meloxicam 30mg was designed using the NanoCrystal ® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds
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, a specialty pharmaceutical company with a high-performing revenue generating contract development and manufacturing division, today announced that it has received a written The FDA has once again put the brakes on Recro Pharma’s efforts to bring its pain killer meloxicam to market, the company has acknowledged
2%) is set for a significant down move after receiving a Complete Response Letter (CRL) from the FDA regarding its marketing A New Drug Application (NDA) for IV meloxicam is currently under review by the U
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Under the prior agreement as amended, Recro Pharma owed Alkermes a milestone payment of $45 million upon approval of IV
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