Unichem gets USFDA nod for generic hypertension tablets

NEW DELHI: Unichem Laboratories today said it has received approval from the US health regulator USFDA for its generic amlodipine besylate tablets used for treating hypertension and coronary artery disease.

"The company has received (ANDA) approval from the US Food an Drug Administration (USFDA) for amlodipine besylate tablets," Unichem Laboratories said in a filing to BSE.

The product in the strengths of 2.5 mg, 5 mg and 10 mg are equivalent to Pfizer Inc's Norvasc tablets in the same strengths, it added.

"Currently there are 6 to 7 companies dominating the US market. The current market size is around USD 45-50 million," Unichem Laboratories said.

The product will be commercialised from the company's Goa facility, it added.

"Amlodipine besylate tablets is a calcium channel blocker indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non fatal cardiovascular events...," Unichem said.

Shares of Unichem Laboratories today closed at Rs 166.65 per scrip on BSE, up 1.21 per cent from its previous close.