Denied FDA approval for pain medication, Recro Pharma tries again

Recro Pharma Inc. of Malvern has announced it will revise and resubmit its application to the FDA seeking approval of the drug melixicam. (Photo courtesy of

Malvern-based Recro Pharma, whose application to market a non-opioid pain medication was denied by the U.S. Food and Drug Administration, plans to resubmit the application by the end of September.

The drug, known as melixicam, is taken intravenously for the management of moderate to severe pain, writes John George at

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In turning down Recro’s application, the FDA said the data suggested that the analgesic effect of the therapy did not meet the agency’s expectations. In addition, the agency raised questions concerning chemistry, manufacturing and the control data Recro provided.

The company’s resubmission will incorporate revised language relating to the product label and additional information relating to the chemistry and manufacturing concerns.

To read the full article, click here.

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