Lupin obtains FDA OK for generic Balcoltra, launches Ganirelix Acetate Injection
Lupin received approval from the Food and Drug Administration for a new generic and also is launching a new generic product.
The FDA approved Lupin’s Minzoya (Levonorgestrel and Ethinyl Estradiol Tablets and Ferrous Bisglycinate Tablets), 0.1 mg/0.02 mg and 36.5 mg, which are a generic of Avion’s Balcoltra.
The product, manufactured at the company’s Pithampur facility in India, is indicated for use by females of reproductive potential to prevent pregnancy.
[Read more: Lupin receives FDA OK for generic Banzel]
Levonorgestrel and Ethinyl Estradiol Tablets and Ferrous Bisglycinate Tablets (RLD Balcoltra) had a market value of about $ 42 million, per IQVIA December 2023 data.
Additionally, Lupin launched Ganirelix Acetate Injection, 250 mcg/0.5 mL, Single-Dose Prefilled Syringe, a generic of Organon USA’s Ganirelix Acetate Injection.
The medication is indicated for the inhibition of premature luteinizing hormone surges in women undergoing controlled ovarian hyperstimulation.
[Read more: Lupin receives tentative FDA nod for 2 generics]
Ganirelix Acetate Injection had a market value of roughly $87 million, per IQVIA December 2023 data.