Lupin gained FDA approval for varenicline tablets (0.5 mg and 1 mg) and launched its already-approved Turqoz (norgestrel and ethinyl estradiol) tablets USP, 0.3 mg/0.03 mg earlier this month.
Global pharmaceutical giant Lupin has made 2 major moves this month: gaining approval for varenicline tablets (Chantix), 0.5 mg and 1 mg, and launching its previously FDA-approved Turqoz tablets (norgestrel and ethinyl estradiol [Lo/Ovral-23]) tablets USP,0.3 mg/0.03 mg in the United States.1,2
Varenicline tablets are indicated for use as an aid to smoking cessation treatment and will be marketed as a generic equivalent of Chantix.1 The approval will offer more options to manage the unhealthy habit among tobacco users.
Varenicline works by partially stimulating nicotinic receptors in the brain of the user, but unlike nicotine, which has a short duration of action that requires multiple daily doses, the drug provides a longer period of action in the body that only requires twice daily use. Previous research has demonstrated that, compared to unassisted smoking cessation attempts, the partial stimulation associated with varenicline decreases tobacco cravings and increases the chances of a successful quit attempt.3
After receiving FDA approval for the drug late this summer, Lupin launched Turqoz (norgestrel and ethinyl estradiol) tablets USP earlier this month. Turqoz, indicated as a contraceptive drug to prevent pregnancy, is the generic equivalent of Lo/Ovral-23 (norgestrel and ethinyl estradiol) tablets from Wyeth Pharmaceuticals.
The launch of the FDA-approved drug will contribute to the annual sales of norgestrel and ethinyl estradiol tablets, estimated in October 2023 to be about $33 million in the US alone.2
Turqoz, a combination hormone medication containing progestin and estrogen, reduces pregnancy by stopping a woman’s egg development each month. Birth control pills of its composition are also used to regulate periods, decrease risks of ovarian cysts, and treat acne.4
Both drugs will be manufactured at Lupin’s Pithampur facility in India.