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| Zydus launches Tamsulosin in US |
| BS Reporter / Mumbai/ Ahmedabad Apr 29, 2010, 00:58 IST |
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Ahmedabad-based pharma major Zydus Cadila has launched Tamsulosin capsules in the US following nod from the US health regulator today. The company rolled out the drug in the US on the same day it received the approval of USFDA.
The company said in a release that it has received an approval from the US Food and Drug Administration to market Tamsulosin capsules (0.4 mg) and has also launched it. Tamsulosin falls in the urology segment and is indicated for the treatment of Benign Prostatic Hyperplasia (BPH). The estimated sales in 2009 for Tamsulosin capsules was $2.79 billion. The company however did not share the details about the kind of volumes it expected from US market after the launch of Tamsulosin capsules.
Following this approval, the group has now approvals for 54 products for the US market and has so far filed 106 abbreviated new drug application (ANDA) since the commencement of filing process in the fiscal 2003-04 fiscal.
A company spokesperson informed that the company had earlier had three more first day launches in the US market in 2008-09 when Lamotrigine IR, Lamotrigine CD, Topiramate IR, and Venlafaxine Hydrochloride were launched on the same day as the FDA approval came in
It may be mentioned here that earlier this month Japanese firm Takeda Pharmaceutical Company Ltd sued Zydus Cadila and its US subsidiary Zydus Pharmaceuticals (USA) Inc alleging that the Indian drugmaker was infringing upon the former’s patent by attempting to manufacture and market the generic version of Prevecid Solu Tab (Lansoprazole) in the US market. Zydus had filed an ANDA to the USFDA seeking approval to manufacture and market lansoprazole, delayed release orally disintegrating tablets (15mg and 30 mg) in the US.
Takeda claimed that this was done prior to the expiration of patent validity of the drug.
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