Glenmark Generics’ US subsidiary has received tentative approval from US Food and Drug Administration department to launch a copycat version of Boehringer Ingelheim’s drug used in treatment of attention-deficit disorder.
The drug, Pramipexole Dihydrochloride, generated sales of $487 million for the 12 month period ending September 2009, according to IMS Health.
In a statement to Bombay Stock Exchange, the company said that it will be able to launch the product by October 2010.
The approval is granted for the 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg strengths.
Boehringer Ingelheim sells the drug under the brand name of Mirapex tablets.
The subsidiary has also received tentative approval for Atomoxetine Hydrochloride capsules, the generic version of Lilly’s Strattera.
This calendar year, the Company has received ten final and five tentative approvals and around 40 such applications are pending for approval with the US drug regulator.
The parent company’s (Glenmark Pharmaceuticals) shares were up Rs 2.10, or 0.75 per cent, on Bombay Stock Exchange. The share was trading at Rs 281.50 during the market hours.
