Orchid receives final USFDA nod for Rasagiline generic formulation

17 Mar 2016 Evaluate

Orchid Pharma has received final approval from the US FDA for its ANDA (Abbreviated New Drug Application) for Rasagiline Tablets 0.5 mg and 1 mg. This product is a FTF (First-to-file) application with a shared 180-day exclusivity for Orchid. Orchid expects to launch this product in Q4 of FY16-17.

Rasagiline Mesylate Tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. With a market size of over $ 300 million and limited generic competition, Orchid hopes to garner a decent market share from this product launch.

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