Lupin Limited’s shares were up by 1.37 per cent after the company received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Minzoya (Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate Tablets), 0.1 mg/0.02 mg and 36.5 mg.
This approval, allows Lupin to market a generic equivalent of Balcoltra (Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate Tablets) 0.1 mg/0.02 mg and 36.5 mg, which is manufactured by Avion Pharmaceuticals LLC. The generic product will be manufactured at Lupin’s Pithampur facility in India.
MinzoyaTM Tablets are indicated for use by females of reproductive potential to prevent pregnancy. The Reference Listed Drug (RLD) Balcoltra® had estimated annual sales of ₹42 million in the U.S. as of IQVIA MAT December 2023. The company informed, this approval strengthens Lupin’s position in the generic pharmaceutical market, providing patients with access to affordable healthcare options.
The shares were up by 1.37 per cent to ₹1,627.10 at 2.43 p.m. on the BSE.