FDA Grants Tentative Approval To GGI For Pramipexole Dihydrochloride Tablets
Published: 28-Dec-2009
Company also received tentaive approval for Atomoxetine Hydrochloride capsules
The FDA has granted tentative approval to Glenmark Generics US (GGI), a subsidiary of Glenmark Generics, for Pramipexole Dihydrochloride tablets, the generic version of Boehringer Ingelheim’s Mirapex tablets.
The tentative approval for Pramipexole Dihydrochloride tablets is for the 0.125mg, 0.25mg, 0.5mg, 1mg, and 1.5mg strengths.
GGI also received tentative approval for Atomoxetine Hydrochloride capsules, the generic version of Lilly’s Strattera.
Atomoxetine Hydrochloride capsules is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). Glenmark’s tentative approval was granted for the 10mg, 18mg, 25mg, 40mg, 60mg, 80mg and 100mg strengths.
The company said that based on the tentative approval for Pramipexole Dihydrochloride tablets, it should be able to launch the product in October 2010, or earlier in certain circumstances.
Reportedly, the company has received ten final and five tentative approvals this calendar year and has well over 40 Abbreviated New Drug Applications (ANDA) pending approval with the FDA.
Glenmark’s current marketing portfolio consists of 49 products authoriSed for distribution in the US.
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