Pregnancy Prevention

• 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…

• CLINICAL_TRIALS trial_result · 2013-06-14
  Clinical Trial Update: A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy [Phase 3]

  Phase 3 trial evaluated the efficacy and safety of DR-103 for pregnancy prevention and has completed with results posted.

• 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…

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• 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.