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news.Impax Laboratories has received final approval from the FDA for its abbreviated new drug application (ANDA) for the generic version of Opana ER (oxymorphone hydrochloride) 30mg.
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Impax Laboratories had received final approval for the 5mg, 10mg, 20mg, and 40mg tablet strengths in June 2010.
Opana is in a group of drugs called narcotic pain relievers, similar to morphine.
Impax Laboratories has entered into an agreement with Endo Pharmaceuticals and Penwest Pharmaceuticals, that manufacture and market Opana ER for the treatment of moderate to severe pain, to grant the company a license to sell a generic of Opana ER on January 1, 2013 or earlier under certain circumstances.
Impax Laboratories has filed a paragraph IV certification on these strengths and is expected to be entitled to 180 days of market exclusivity upon product launch.
Impax Laboratories’ generic division, Global Pharmaceuticals is expected to commercialise the product on January 1, 2013 or earlier under certain circumstances.