Orchid receives final USFDA nod for Rasagiline generic formulation
Chennai, India | March 17, 2016
Chennai-based Pharma major, Orchid Pharma Ltd (Orchid) today announced that it 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 FY 16-17. Rasagiline Mesylate Tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease.
With a market size of over US$ 300 million and limited generic competition, Orchid hopes to garner a decent market share from this product launch.
“This media release includes forward looking statements and indications, which are based on current expectations and forecasts about future events. Such statements and indications involve known and unknown risks, uncertainties and other factors and may cause actual results to materially differ. Such factors include, but are not limited to, changes in local and global economic conditions, Orchid’s ability to successfully implement strategies, the market acceptance and demand of Orchid’s products and services, Orchid’s growth rates, expansion, technological change and Orchid’s exposure to market risks. By their nature, these statements and indications are only estimates and actual results could differ from these in the future.”