Regulatorische Updates
Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit
#oral contraceptive ×
Regulatorische Updates
17. Sept. 2026•1 Min. Lesezeit
FDA Approves Lupin Pharmaceuticals' FYAVOLV (Norethindrone Acetate/Ethinyl Estradiol)
The FDA has approved ANDA204213 for FYAVOLV, a prescription oral tablet combining norethindrone acetate and ethinyl estradiol, manufactured by Lupin Pharmaceuticals.
Regulatorische Updates
10. Sept. 2026•1 Min. Lesezeit
FDA Approves ANDA 076335 for TRI-PREVIFEM Oral Tablet
The FDA approved ANDA 076335 for the oral tablet TRI-PREVIFEM, containing ethinyl estradiol and norgestimate, sponsored by PH HEALTH. The product is listed as discontinued.
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
FDA Approves ORSYTHIA (ANDA077099) Oral Tablet
FDA has approved ANDA077099 for ORSYTHIA, an oral tablet containing ethinyl estradiol 0.02 mg and levonorgestrel 0.1 mg, sponsored by PH Health.
Regulatorische Updates
28. Aug. 2026•1 Min. Lesezeit
FDA Updates LOESTRIN 21 1.5/30 (NDA 017875) Submissions
FDA records show multiple labeling and manufacturing submissions for LOESTRIN 21 1.5/30, a discontinued oral contraceptive tablet, with the latest activity in May 2022.
Regulatorische Updates
25. Aug. 2026•1 Min. Lesezeit
FDA Approves ANDA078965 for Norethindrone/Ethinyl Estradiol/Ferrous Fumarate Tablet
The FDA has approved ANDA078965 for a prescription oral tablet combining norethindrone, ethinyl estradiol, and ferrous fumarate, submitted by BARR.