Unichem Labs gets USFDA nod to market generic Amitriptyline HCL Tablets

Drug firm Unichem Laboratories Limited on Thursday, May 20, 2021, said that it has received approval from the US health regulator United States Food and Drug Administration (USFDA) to market generic Amitriptyline HCL Tablets that are used in the treatment of depression.

Unichem in a regulatory filing at BSE said, "It has received ANDA approval for its Amitriptyline HCl Tablets USP, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg and 150 mg from the USFDA to market a generic version of ELAVIL (Amitriptyline Hydrochloride) 10 mg, 25 mg, 50 mg, 75 mg, 100 mg and 150 mg of AstraZeneca Pharmaceuticals LP."

Amitriptyline HCL tablets are a generic version of Elavil of AstraZeneca Pharmaceuticals. The drug is indicated for the relief of symptoms of depression. The product will be commercialized from Unichem's Goa plant.

Unichem Laboratories is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in several markets across the world.

Shares of Unichem Laboratories closed 27.70 points or 8.354 per cent up from the previous close of Rs 332.20 at Rs 359.90 on NSE.