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The US health regulator has provided its final approval to the Chennai based Orchid Pharma for its generic version of rasagiline tablets that are used in the treatment of Parkinson’s disease.
Orchid Pharma has said in a BSE filing that the nod from the USFDA for the first-to-file abbreviated new drug application (ANDA) with shared 180-day marketing exclusivity is for the strengths of 0.5 mg and 1 mg.
It further added that “Orchid expects to launch this products in the fourth quarter of fiscal 2016-17.”
Orchid has said that “With a market size of over USD 300 million and limited generic competition”, It “hopes to garner a decent market share from this product launch”.
