The US Food and Drug Administration (FDA) has given its tentative approval for pramipexole dihydrochloride tablets – of 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, and 1.5 mg strengths – of Glenmark Generics Ltd, which is a Glenmark Pharmaceuticals Ltd. subsidiary.

Going by the IMS data, pramipexole dihydrochloride tablets - the Parkinsons’ disease treatment drug, and the generic version of Boehringer Ingelheim’s Mirapex tablets - generated $487-million sales during the year ending September 2009.

Having the secured the FDA’s tentative approval for pramipexole dihydrochloride tablets, Glenmark Generics has, during this calendar year, received ten final and five tentative approvals from the US agency. In addition, the company has more than 40 Abbreviated New Drug Applications (ANDA) that are currently pending approval with the FDA.

With the tentative pramipexole dihydrochloride approval, Glenmark would likely launch the drug by October next year. The company’s marketing portfolio, as of now, comprises as many as 49 products that it has been authorized for distribution in the US.

In addition to the pramipexole dihydrochloride tablets’ tentative approval, Glenmark has also received yet another tentative approval for the 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg strengths of Atomoxetine hydrochloride capsules, the generic version of Lilly’s Strattera.

As per IMS Health statistics, Atomoxetine hydrochloride capsules, a treatment of attention deficit/hyperactivity disorder (ADHD), generated $498 million in 12-month sales till September 2009.