US FDA grants approvals to Jubilant for hypertension and anti-allergic drugs

Jubilant Life Sciences Ltd, an integrated pharmaceuticals and life sciences company, has received abbreviated new drug application (ANDA) final approval from the US Food and Drug Administration (US FDA) for irbesartan tablets USP, 75 mg, 150 mg, & 300 mg, and cetirizine hydrochloride tablets (chewable), 5 mg and 10 mg.
 
Irbesartan tablets is the generic version of Avapro (of Sanofi-Aventis), which is used for treating hypertension and nephropathy in type II diabetic patients. The total market size for irbesartan tablets as per IMS is approximately $50 million per annum.
 
Cetirizine hydrochloride tablets (chewable) is the generic version of Zyrtec chewable tablets (of Mcneil), used as an anti-histamine for the treatment of allergies.
 
As on December 31, 2014, Jubilant Life Sciences had a total of 781 filings for formulations of which 333 have been approved in various regions globally. This includes 72 ANDAs filed in the US, of which 35 have been approved and 46 dossier filings in Europe. So far, the company has received 9 ANDA approvals during FY 2015.