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Unichem Labs gets USFDA nod to market generic antidepressant tablets

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.

Unichem Laboratories. Photo: UnichemLabs.com

Unichem Laboratories. Photo: UnichemLabs.com

Press Trust of India New Delhi

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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.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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First Published: May 20 2021 | 4:08 PM IST

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