Pregnancy Prevention

• FDA approval · 2025-10-01
  FDA Approved: MIUDELLA — Supplemental Application (Sebela Women's Health Inc.)

  FDA approved a supplemental application for MIUDELLA (copper intrauterine device) from Sebela Women's Health Inc. This action updates the pr…

• FDA approval · 2025-09-30
  FDA Approved: LEVONORGESTREL — Original Application (Camber Consumer Care Inc)

  FDA approved Camber Consumer Care Inc's original application for levonorgestrel, a generic oral contraceptive.

• FDA approval · 2025-05-02
  FDA Approved: AVERI — Original Application (Avion Pharmaceuticals, LLC)

  FDA approved AVERI, a desogestrel and ethinyl estradiol combination oral contraceptive, developed by Avion Pharmaceuticals under an Original…

• FDA approval · 2023-09-25
  FDA Approved: JUNEL FE 28 DAY — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for JUNEL FE 28 DAY, a norethindrone acetate/ethinyl estradiol/ferrous fumarate oral contraceptive.

• FDA approval · 2023-08-16
  FDA Approved: DROSPIRENONE AND ETHINYL ESTRADIOL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Camber Pharmaceuticals' generic drospirenone/ethinyl estradiol, making this combined oral contra…

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• FDA approval · 2022-04-29
  FDA Approved: LUTERA — Supplemental Application (Mayne Pharma Inc.)

  FDA approved a supplemental application for LUTERA (levonorgestrel and ethinyl estradiol) filed by Mayne Pharma Inc.

• FDA approval · 2022-04-29
  FDA Approved: NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for the norethindrone/ethinyl estradiol/ferrous fumarate oral contraceptive manufactured by Mylan Ph…

• FDA approval · 2022-04-29
  FDA Approved: TWIRLA — Supplemental Application (Agile Therapeutics, Inc.)

  The FDA approved a supplemental application for TWIRLA (levonorgestrel/ethinyl estradiol) from Agile Therapeutics, Inc., indicating approval…

• FDA approval · 2020-07-17
  FDA Approved: DROSPIRENONE AND ETHINYL ESTRADIOL — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approves Glenmark's supplemental application for a generic drospirenone/ethinyl estradiol product (oral contraceptive).

• FDA approval · 2020-04-30
  FDA Approved: VESTURA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's supplemental application for VESTURA, a generic combination oral contraceptive containing drospirenone and ethinyl estra…

• FDA approval · 2019-12-23
  FDA Approved: DEPO-SUBQ PROVERA — Supplemental Application (Pharmacia & Upjohn Company LLC)

  FDA approved a supplemental application for DEPO-SUBQ PROVERA (medroxyprogesterone acetate) from Pharmacia & Upjohn Company LLC.

• FDA approval · 2017-08-09
  FDA Approved: LEVONEST — Supplemental Application (Northstar Rx LLC)

  FDA approves a supplemental application for LEVONEST (levonorgestrel and ethinyl estradiol) from Northstar Rx LLC.

• FDA approval · 2017-08-09
  FDA Approved: AMETHYST — Supplemental Application (Teva Pharmaceuticals, Inc.)

  FDA approved a supplemental application for AMETHYST (levonorgestrel and ethinyl estradiol) submitted by Teva Pharmaceuticals, Inc. The supp…

• FDA approval · 2017-08-09
  FDA Approved: ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Ethynodiol Diacetate and Ethinyl Estradiol from Mylan Pharmaceuticals Inc., a combined oral …

• FDA approval · 2017-02-02
  FDA Approved: NEXESTA FE — Original Application (Aurobindo Pharma Limited)

  FDA approved NEXESTA FE, a generic fixed-dose combination oral contraceptive containing norethindrone, ethinyl estradiol, and ferrous fumara…

• FDA approval · 2015-06-12
  FDA Approved: LEVONORGESTREL AND ETHINYL ESTRADIOL — Original Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark's levonorgestrel and ethinyl estradiol combination via an Original Application, establishing a new approved oral c…

• FDA approval · 2015-04-01
  FDA Approved: ENSKYCE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for ENSKYCE (desogestrel and ethinyl estradiol), resulting in an approved chang…

• FDA approval · 2014-02-25
  FDA Approved: ALTAVERA — Supplemental Application (Xiromed, LLC.)

  FDA approved a supplemental application for ALTAVERA, a combined oral contraceptive containing levonorgestrel and ethinyl estradiol, submitt…

• FDA approval · 2013-03-28
  FDA Approved: RIVELSA — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Rivelsa, Teva's oral contraceptive, under an original NDA for pregnancy prevention.

• FDA approval · 2012-02-13
  FDA Approved: DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Sandoz's Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium, likely re…

• FDA approval · 2010-09-27
  FDA Approved: INTROVALE — Original Application (Xiromed, LLC.)

  FDA approved the original application (ANDA) for INTROVALE, a generic combination oral contraceptive containing levonorgestrel and ethinyl e…

• FDA approval · 2007-10-26
  FDA Approved: TRI-LEGEST FE 28 DAY — Original Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved the generic oral contraceptive Tri-Legest FE 28 Day (norethindrone acetate and ethinyl estradiol) via an original ANDA for …

• FDA approval · 2007-01-26
  FDA Approved: YAZ — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approved Bayer’s supplemental application for YAZ (drospirenone and ethinyl estradiol), authorizing updates to the product labeling.