Lupin receives FDA OK for generic Chantix, launches generic Lo/Ovral-28
Lupin has received the Food and Drug Administration’s nod for a new generic, and the company also has launched a new generic.
The FDA has approved Lupin's Varenicline Tablets, 0.5 mg and 1 mg, which is the generic of PF Prism C.V.’s Chantix.
The product will be manufactured at Lupin’s Pithampur facility in India.
[Read more: Lupin obtains FDA OK for generic Bromfenac, tentative nod for generic Invokana]
Varenicline Tablets, 0.5 mg and 1 mg are indicated for use as an aid to smoking cessation treatment.
Varenicline Tablets had a U.S. market value of $430 million, per IQVIA October 2023 data.
Lupin has launched Turqoz (Norgestrel and Ethinyl Estradiol) Tablets,0.3 mg/0.03 mg, which is the generic of Wyeth’s Lo/Ovral-28.
Generic Turqoz is a contraceptive drug indicated to prevent pregnancy.
Norgestrel and Ethinyl Estradiol Tablets (Lo/Ovral-28) had a U.S. market value of roughly $33 million, per IQVIA October 2023 data.
[Read more: Lupin receives FDA OK for generic Banzel]