Drug firm Jubilant Life Sciences has received approval from the US health regulator for generic Irbesartan and Cetirizine Hydrochloride tablets used for treatment of hypertension and allergies respectively.
The company has received final approval from US Food and Drug Administration for its abbreviated new drug application for Irbesartan tablets in the strengths of 75 mg, 150 mg, 300 mg and for chewable Cetirizine Hydrochloride tablets in the strengths of 5 mg and 10 mg, Jubilant Life Sciences said.
The total market size for Irbesartan tablets as per IMS is approximately USD 50 million per annum, it added.
Irbesartan tablets are the generic version of Sanofi- Aventis Avapro tablets used for treatment of hypertension and nephropathy in type II diabetic patients.
Cetirizine Hydrochloride tablets are generic of Mcneil's Zyrtec chewable tablets and are used as anti-histamine for the treatment of allergies, Jubilant Life Sciences said.
Jubilant Life Sciences had a total of 781 filings for formulations of which 333 have been approved in various regions globally as on December 31, 2014.
This includes 72 abbreviated new drug applications (ANDAs) filed in the US, of which 35 have been approved and 46 Dossier filings in Europe. So far, we have received 9 ANDA approvals during FY 2015, the company said.
Shares of Jubilant Life Sciences today closed at Rs 164.20 on BSE, up 4.22 per cent from previous close.
