The company has received abbreviated new drug application (ANDA) approval for its Amiodarone tablets, USP, 200 mg from the United States Food and Drug Administration (USFDA), Unichem Labs said in a filing to the BSE.
Drug firm Unichem Laboratories on Wednesday said it has received approval from the US health regulator for its Amiodarone tablets used to treat irregular heartbeat. The approved product is a generic version of Wyeth Pharmaceuticals Inc's Cordarone tablets.
The company has received abbreviated new drug application (ANDA) approval for its Amiodarone tablets, USP, 200 mg from the United States Food and Drug Administration (USFDA), Unichem Labs said in a filing to the BSE.
Amiodarone tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated.
Unichem Labs said the product will be commercialised from its Ghaziabad, Uttar Pradesh, plant.
Shares of Unichem Labs were trading 0.14 per cent higher at Rs 210.75 apiece on the BSE. PTIANS .