Business · 25/06/2013

FDA Clears Oxymorphone Hydrochloride Extended-Release Tablets for Approval

The US Food and Drug Administration (FDA) has ruled that Oxymorphone Hydrochloride (OPANA ER) Extended-Release Tablet products, approved under NDA 21-610, were not withdrawn from sale due to safety or effectiveness concerns, allowing the FDA to approve future abbreviated new drug applications (ANDAs) for these products.