Lupin gets tentative USFDA nod for generic anti-depressant

The tentative approval by the United States Food and Drug Administration (USFDA) is for multiple strengths of 12.5 mg, 25 mg and 37.5 mg of the generic version of Apotex Technologies' Paxil CR tablets of similar strengths

PTI August 26, 2016 15:22:42 IST
Lupin gets tentative USFDA nod for generic anti-depressant

New Delhi: Pharma major Lupin Friday said it has received tentative approval for its generic version of anti-depressant Paroxetine extended-release tablets from the US health regulator.

Lupin gets tentative USFDA nod for generic antidepressant

Reuters

The tentative approval by the United States Food and Drug Administration (USFDA) is for multiple strengths of 12.5 mg, 25 mg and 37.5 mg of the generic version of Apotex Technologies' Paxil CR tablets of similar strengths, Lupin said in a BSE filing.

The drug is indicated for treatment of major depressive disorder, panic disorder, social anxiety disorder and premenstrual dysphoric disorder.

Citing IMS MAT data till June 2016, Lupin said Paxil CR had US sales of $127.4 million.

Shares of Lupin were trading at Rs 1,524.70, up 0.14 per cent in the afternoon trade on BSE.

Updated Date:

Find latest and upcoming tech gadgets online on Tech2 Gadgets. Get technology news, gadgets reviews & ratings. Popular gadgets including laptop, tablet and mobile specifications, features, prices, comparison.

also read

Boost to Indian cos: FDA nod to Dr Reddy's, Lupin for anti-depressant drug
Business

Boost to Indian cos: FDA nod to Dr Reddy's, Lupin for anti-depressant drug

Aurobindo Pharma, Dr Reddy's Laboratories, Lupin, Sun Pharma Global FZE, and Torrent Pharmaceuticals have received the regulatory nod to market duloxetine in various strengths, besides Teva Pharmaceuticals, USA, says a press release issued by the FDA.

Lupin to enter US HIV drug market after FDA green light
Business

Lupin to enter US HIV drug market after FDA green light

The company's product is indicated in combination with other antiretrovirals or alone for the treatment of HIV-1 infection, it said.

Lupin receives USFDA approval to market fungal infection drug
Politics

Lupin receives USFDA approval to market fungal infection drug

Company's US subsidiary Gavis Pharmaceuticals LLC has received final approvals to market "its Voriconazole tablets, 50 mg & 200 mg and Voriconazole Oral Suspension, 40 mg/mL from the United States Food and Drug Administration