Contraception

• FDA approval · 2011-08-02
  FDA Approved: SYEDA — Supplemental Application (Xiromed, LLC.)

  FDA approved a supplemental application for SYEDA, a drospirenone and ethinyl estradiol combination oral contraceptive, manufactured by Xiro…

• FDA approval · 2011-05-18
  FDA Approved: INTROVALE — Supplemental Application (Xiromed, LLC.)

  FDA approved a supplemental application for INTROVALE (levonorgestrel and ethinyl estradiol) from Xiromed, LLC., for this combined oral cont…

• FDA approval · 2011-03-28
  FDA Approved: LORYNA — Original Application (Xiromed, LLC.)

  FDA approved LORYNA as an Original Application for a generic drospirenone and ethinyl estradiol tablet by Xiromed, LLC.

• CLINICAL_TRIALS trial_result · 2011-01-25
  Clinical Trial Update: Efficacy and Safety Study for an Oral Contraceptive Containing Folate [Phase 3]

  Phase 3 trial evaluating efficacy and safety of a folate-containing oral contraceptive has completed and results were posted in 2011.

• FDA approval · 2010-10-15
  FDA Approved: MEDROXYPROGESTERONE ACETATE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Medroxyprogesterone Acetate submitted by Prasco Laboratories.

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• FDA approval · 2010-07-22
  FDA Approved: NORETHINDRONE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's original ANDA for norethindrone tablets, a progestin used as a generic contraceptive.

• CLINICAL_TRIALS trial_result · 2010-06-09
  Clinical Trial Update: Effects of St. John's Wort on the Oral Contraceptive Hormone Levonorgestrel [Phase 4]

  Phase 4 clinical trial evaluating the effects of St. John's Wort on the oral contraceptive levonorgestrel.

• CLINICAL_TRIALS trial_result · 2010-05-25
  Clinical Trial Update: Study to Evaluate Cycle Control With Norgestimate/Ethinyl Estradiol and Drospirenone/Ethinyl Estradiol in Healthy Sexually Active Females [Phase 4]

  Phase 4 clinical trial evaluating cycle control of two combined oral contraceptives in healthy sexually active females has completed with re…

• CLINICAL_TRIALS trial_result · 2010-05-17
  Clinical Trial Update: A Bioequivalence Study of IMPLANON and Radiopaque IMPLANON (34528)(P05720) [Phase 3]

  A Phase 3 bioequivalence study comparing IMPLANON with radiopaque IMPLANON has completed with results posted.

• CLINICAL_TRIALS trial_result · 2010-03-31
  Clinical Trial Update: A Trial in Healthy Female Subjects to Compare the Pharmacokinetics of Ethinyl Estradiol of NuvaRing®, a Contraceptive Patch (EVRA(TM)) and an Oral Contraceptive (Microgynon® 30) (Study 34237 (P06650)) (COMPLETED) [Phase 4]

  Phase 4 trial comparing pharmacokinetics of ethinyl estradiol between NuvaRing contraceptive patch and a combined oral contraceptive in heal…

• FDA approval · 2009-11-06
  FDA Approved: JINTELI — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves JINTELI as an original generic application for a norethindrone acetate and ethinyl estradiol contraceptive, submitted by Teva P…

• FDA approval · 2009-10-01
  FDA Approved: MIRENA — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  The FDA granted approval for a supplemental application for MIRENA (levonorgestrel intrauterine system) submitted by Bayer HealthCare Pharma…

• FDA approval · 2008-10-24
  FDA Approved: CAMRESE LO — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Camrese Lo under an original application; it is a combined oral contraceptive containing levonorgestrel and ethinyl estradiol.

• CLINICAL_TRIALS trial_result · 2008-10-21
  Clinical Trial Update: PARIS or PAtch RIng Study: A Trial to Evaluate NuvaRing Versus OrthoEvra [Phase 4]

  Phase 4 trial comparing NuvaRing to Ortho Evra for contraception; the study has completed.

• FDA approval · 2008-07-21
  FDA Approved: MIRENA — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for MIRENA (levonorgestrel) submitted by Bayer HealthCare Pharmaceuticals Inc. The action is a suppl…

• 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.

• FDA approval · 2006-05-25
  FDA Approved: CAMRESE — Original Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved CAMRESE, an oral contraceptive, under an Original Application submitted by Teva Pharmaceuticals USA, Inc. The product conta…