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 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.
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.
