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Impax confirms patent challenge for generic Nuedexta
HAYWARD, Calif. — Impax Labs has hit a roadblock in its attempts to market a generic pseudobulbar affect treatment.
Impax said that Avanir Pharmaceuticals, Avanir Holding Co. and the Center for Neurologic Study filed a patent infringement suit in the U.S. District Court of Delaware in connection with Impax's attempt to market a generic version of Nuedexta capsules (dextromethorphan hydrobromide and quinidine sulfate) in the 20-mg/10-mg strength.
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Lupin receives FDA approval for generic Ultram ER tablets
BALTIMORE — Lupin has received final approval from the Food and Drug Administration for its version of a drug designed to treat moderate to moderately severe chronic pain in adults who require around-the-clock treatment for an extended period of time.
Lupin said that it received final approval for its abbreviated new drug application for tramadol hydrochloride extended-release tablets in the 100-mg, 200-mg and 300-mg strengths. The drug is a generic version of Ultram ER tablets, which is marketed by Johnson & Johnson subsidiary Ortho-McNeil-Janssen Pharmaceuticals.