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news.The US Food and Drug Administration (FDA) has approved TWi Pharmaceuticals' abbreviated new drug application (ANDA) for megestrol acetate 125mg/ml oral suspension, which is the generic equivalent to Par Pharmaceutical's Megace ES.
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The company has already completed the pre-launch preparation of the generic drug and will now be entitled to 180 days of marketing exclusivity under Hatch Waxman rules.
According to the company, the launch of the generic drug has been enjoined by Par’s posting of a $10m bond with the District Court of Maryland pending Par’s appeal to the US Court of Appeals for the Federal Circuit.
In return to Par’s appeal, TWi has filed a motion in the Federal Circuit Court to dissolve the injunction.
The generic drug can be launched immediately, in case TWi succeeds on its motion to dissolve the injunction or the Federal Circuit rejects Par’s appeal.
Par’s Megace ES is used to treat appetite loss, severe malnutrition, or unexplained, significant weight loss in AIDS patients.
The drug is a reformulation of megestrol acetate oral suspension and is prescribed for AIDS patients to help improve appetite and gain weight.