Unichem Labs gets FDA nod for new drug
image for illustrative purpose
New Delhi Drug firm Unichem Laboratories on Thursday said it has received approval from the US health regulator to market generic Amitriptyline HCl tablets used in the treatment of depression.
The company has received abbreviated new drug application (ANDA) approval to market its Amitriptyline HCl tablets USP, in the strengths of 10 mg, 25 mg, 50 mg, 75 mg, 100 mg and 150 mg from the United States Food and Drug Administration (USFDA), Unichem Laboratories said in a regulatory filing.
The product is a generic version of AstraZeneca Pharmaceuticals LP's Elavil tablets in the same strengths, it added. The tablets will be commercialised from the company's Goa plant, Unichem Labs said. Amitriptyline HCl Tablets are indicated for the relief of symptoms of depression, it added. Shares of Unichem Laboratories closed at Rs 358.60 per scrip on BSE, up 7.43 per cent from its previous close.
