FDA accepts Endo’s resubmission for Opana ER
CHADDS FORD, Pa. — The Food and Drug Administration has accepted a resubmission by Endo Pharmaceuticals of a regulatory application for an opioid pain drug designed to thwart abuse, Endo said.
The agency had declined to approve Endo’s Opana ER (oxymorphone hydrochloride) in January for reasons that the company did not specify, though the agency did not request additional clinical studies in its statement, known as a complete response letter.
The drug is designed to prevent abuse by being resistant to crushing, which drug abusers often do with opioid painkillers so they can snort or inject them.
The agency plans to take action on the resubmission in December.
FDA panel recommends approval of Shire’s Firazyr
DUBLIN — A Food and Drug Administration expert panel has recommended approval of a drug made by Shire for a rare immune system disorder, the drug maker said.
Shire said the FDA’s Pulmonary-Allergy Drugs Advisory Committee recommended approval of Firazyr (icatibant) for treating acute hereditary angioedema attacks in adults. The committee also voted 11-1 to recommend approval of self-administration of the drug by patients.
HAE is a genetic and potentially fatal immune system disorder that causes swelling of the face and airways and result in airway blockage.
The FDA is not obligated to follow the recommendations made by advisory committees, but generally considers them when deciding whether or not to grant approval to a drug.
Mylan’s generic Entocort EC to enter market
PITTSBURGH — A generic drug made by Mylan for Crohn’s disease does not infringe on the patent for the branded drug, a federal court ruled Thursday.
Mylan said the U.S. District Court for the District of Delaware ruled that Mylan’s regulatory approval application for budesonide capsules in the 3-mg strength does not violate the patent for the branded drug, AstraZeneca’s Entocort EC.
The Food and Drug Administration approved Mylan’s product last month, and the company said it plans to launch immediately. Budesonide capsules in the 3-mg strength had sales of about $350 million for the 12 months ended in March, according to IMS Health.