Orchid Pharma gets USFDA nod for Parkinson's drug

Expects to launch the drug in fourth quarter of 2016-17 fiscal

Orchid Pharma has announced it has received final approval from the US drug regulator to its Rasagiline Tablets 0.5 mg and 1 mg for treating symptoms of Parkinson's disease.

The product is a first-to-file application with a 180-day shared exclusivity, it said.

The company received approval for its Abbreviated New Drug Application (ANDA), an application for approval of a generic drug in the US, for Rasagiline tablets, upto particular strenght.

The company is expected to launch its product in the fourth quarter of 2016-17 fiscal.

Rasagiline Mesylate tablets are indicated for treatment of 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," said the company.