Lupin shares trade higher on USFDA nod for varenicline tablets

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Shares of Lupin on December 6 saw intraday gains as the company received approval from the US Food and Drug Administration (USFDA) for its varenicline tablets.

“…. has received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application for Varenicline tablets, 0.5 mg and 1 mg, to market a generic equivalent of Chantix Tablets, 0.5 mg and 1 mg, of PF Prism C.V.,” the company said in a press release

The product will be manufactured at Lupin’s Pithampur facility in India.

Varenicline tablets are indicated for use as an aid to smoking cessation treatment.

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On December 1, the company launched Turqoz (Norgestrel and Ethinyl Estradiol) Tablets USP, 0.3 mg/0.03 mg, after having received an approval from USFDA.

The tablets are the generic equivalent of Lo/Ovral-28 (Norgestrel and Ethinyl Estradiol) tablets of Wyeth Pharmaceuticals LLC and is a contraceptive drug indicated to prevent pregnancy.

On November 24, the company received tentative approval from USFDA for its abbreviated new drug application for canagliflozin tablets.

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