Contraception
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EMA withdrawal · 2014-08-26EMA Withdrawn: Ioa (nomegestrol acetate;estradiol) — Organon N.V.
EMA has withdrawn the contraceptive product Ioa (nomegestrol acetate and estradiol) from Organon N.V.'s portfolio.
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FDA approval · 2014-05-29FDA Approved: MIRENA — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
The FDA has approved a supplemental application for MIRENA (levonorgestrel) submitted by Bayer HealthCare Pharmaceuticals.
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FDA approval · 2014-05-08FDA Approved: SKYLA — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
FDA approved a supplemental application for SKYLA (levonorgestrel), Bayer's intrauterine contraceptive device, resulting in labeling updates…
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FDA approval · 2014-04-16FDA Approved: XULANE — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved an original application for XULANE, a generic norelgestromin and ethinyl estradiol contraceptive patch from Mylan Pharmaceutica…
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CLINICAL_TRIALS trial_result · 2014-04-07Clinical Trial Update: LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study [Phase 3]
Phase 3 clinical trial update evaluating LCS12 versus combined oral contraceptive users; study completed with results posted in 2014.
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CLINICAL_TRIALS trial_result · 2014-03-24Clinical Trial Update: Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women [NA]
Clinical trial update for misoprostol use before IUD insertion in nulliparous women; status completed with results posted in 2014.
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FDA approval · 2014-03-20FDA Approved: LARIN 1.5/30 — Original Application (Northstar Rx LLC)
FDA approved LARIN 1.5/30 (norethindrone acetate/ethinyl estradiol) under an original ANDA from Northstar Rx LLC for contraception. The prod…
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FDA approval · 2014-02-25FDA Approved: BRIELLYN — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
The FDA approved a supplemental application for BRIELLYN, a norethindrone and ethinyl estradiol oral contraceptive from Glenmark Pharmaceuti…
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FDA approval · 2014-02-21FDA Approved: PORTIA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for PORTIA (levonorgestrel and ethinyl estradiol) from Teva Pharmaceuticals USA, Inc., updating …
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FDA approval · 2014-01-28FDA Approved: KURVELO — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for Kurvelo (levonorgestrel and ethinyl estradiol) by Lupin Pharmaceuticals, Inc.
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CLINICAL_TRIALS trial_result · 2013-12-30Clinical Trial Update: Pharmacokinetic and Pharmacodynamic Study of Cyclofem [Phase 1, Phase 2]
Phase 1/2 pharmacokinetic and pharmacodynamic study of Cyclofem in contraception completed with results posted.
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CLINICAL_TRIALS trial_result · 2013-12-11Clinical Trial Update: A Study to Evaluate the Efficacy and Safety of DR-102 for the Prevention of Pregnancy [Phase 3]
Phase 3 trial evaluating DR-102 for prevention of pregnancy has completed with results posted in 2013.
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CLINICAL_TRIALS trial_result · 2013-11-25Clinical Trial Update: Randomized Controlled Trial of Adjunctive Social Media for More Effective Contraceptive Counseling [NA]
A randomized controlled trial evaluating adjunctive social media to improve contraceptive counseling has completed. No efficacy results are …
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FDA approval · 2013-11-14FDA Approved: FEIRZA 1/20 — Original Application (Xiromed LLC)
FDA approved FEIRZA 1/20 from Xiromed LLC as an original ANDA for a combined oral contraceptive containing norethindrone acetate and ethinyl…
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FDA approval · 2013-10-09FDA Approved: LEVONORGESTREL AND ETHINYL ESTRADIOL — Original Application (Mylan Pharmaceuticals Inc.)
The FDA approved Mylan's generic combination oral contraceptive Levonorgestrel and Ethinyl Estradiol under an Original Abbreviated New Drug …
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FDA approval · 2013-10-04FDA Approved: NUVARING — Supplemental Application (Advanz Pharma (US) Corp.)
The FDA approved a supplemental application for Nuvaring (etonogestrel and ethinyl estradiol) filed by Advanz Pharma (US) Corp., approving t…
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CLINICAL_TRIALS trial_result · 2013-09-24Clinical Trial Update: Evaluation of Participant Responses to Educational Counseling About Different Combined Hormonal Contraceptive Choices (P06557)
A completed clinical trial evaluating participant responses to educational counseling about different combined hormonal contraceptive choice…
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FDA label_change · 2013-09-13FDA Approved: SKYLA — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
FDA approved a supplemental application for SKYLA (levonorgestrel intrauterine system) submitted by Bayer HealthCare Pharmaceuticals Inc. to…
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FDA approval · 2013-08-26FDA Approved: MICROGESTIN FE 1/20 — Original Application (Dr. Reddy's Laboratories Inc.)
FDA approved Microgestin FE 1/20 (norethindrone acetate/ethinyl estradiol with ferrous fumarate) under an Original Application (ANDA) for co…
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FDA approval · 2013-08-23FDA Approved: LARIN FE 1.5/30 — Original Application (Northstar Rx LLC)
FDA approved Northstar Rx LLC's original application for LARIN FE 1.5/30, a generic combined oral contraceptive containing norethindrone ace…
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FDA approval · 2013-08-07FDA Approved: MIRENA — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
The FDA approved a supplemental application for MIRENA (levonorgestrel) from Bayer HealthCare Pharmaceuticals Inc., indicating an approved a…
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FDA label_change · 2013-08-07FDA Approved: SKYLA — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
FDA approved a supplemental application for SKYLA (levonorgestrel) submitted by Bayer HealthCare Pharmaceuticals Inc. The approval updates S…
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FDA approval · 2013-08-01FDA Approved: AZURETTE — Original Application (Mayne Pharma Inc.)
FDA approved Mayne Pharma's Azurette, an oral contraceptive containing desogestrel and ethinyl estradiol under an original ANDA submission.
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FDA approval · 2013-07-12FDA Approved: DESOGESTREL AND ETHINYL ESTRADIOL — Original Application (Mayne Pharma Inc.)
FDA approves Mayne Pharma's desogestrel and ethinyl estradiol as an Original Application generic contraceptive product.
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CLINICAL_TRIALS trial_result · 2013-06-11Clinical Trial Update: Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel [Phase 1]
A Phase 1 crossover trial evaluated bioequivalence between two oral levonorgestrel formulations to support their interchangeability for cont…