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 bizjournals.com.
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.
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