FDA Approves Lupin Pharmaceuticals' FYAVOLV (Norethindrone Acetate/Ethinyl Estradiol)

The U.S. Food and Drug Administration has approved the Abbreviated New Drug Application (ANDA) 204213 for FYAVOLV, a prescription oral tablet. FYAVOLV, manufactured by Lupin Pharmaceuticals, Inc., contains a fixed‑dose combination of norethindrone acetate (0.5 mg or 1 mg) and ethinyl estradiol (0.0025 mg or 0.005 mg) in two tablet strengths. The product is classified as a human prescription drug and is indicated for oral administration. FDA submissions included manufacturing (CMC) and labeling supplements, with the most recent labeling submission approved on 2024‑02‑16. The approval adds to Lupin’s portfolio of hormonal contraceptive products and provides additional options for prescribers.