Levonorgestrel News and Research

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Contraception drospirenone raises risk for blood clots

Two new drug safety studies conducted by researchers at Boston University School of Medicine (BUSM) provide strong evidence that women taking oral contraception with drospirenone have an increased risk of nonfatal venous thromboembolism, or blood clots, compared to women taking oral contraception with levonorgestrel.

21 Apr 2011

Drospirenone doesn't carry any risk of gall bladder disease

Drospirenone, the top-selling oral contraceptive marketed as Yaz or Yasmin in the U.S. and Canada, doesn't carry any more risk of gall bladder disease than the older generation of birth control pills, despite claims by some consumers and lawyers in both countries, according to a new study by University of British Columbia and Vancouver Coastal Health Research Institute researcher Mahyar Etminan.

19 Apr 2011

U.S. District Court rules in favor of Watson in generic SEASONIQUE patent infringement suit

Watson Pharmaceuticals, Inc., a leading integrated global pharmaceutical company, today confirmed that it has received a favorable decision from the U.S. Court of Appeals for the Federal Circuit related to its ongoing patent challenge in connection with Watson's Abbreviated New Drug Application seeking FDA approval to market a generic version of Teva Women's Health, Inc.'s SEASONIQUE and ethinyl estradiol.

28 Mar 2011

Study finds increased risk of VTE during first year of combination oral contraceptive usage

Bayer HealthCare Pharmaceuticals Inc. today announced that interim results from a large, prospective, observational cohort safety study offer insights into the increased risk of venous thromboembolism (VTE), or blood clots, which is a well-established risk in women who use combination oral contraceptives (COCs), also known as "the Pill".

25 Mar 2011

Japan MHLW approves Sosei's NorLevo emergency contraceptive pill

Sosei Group Corporation, the biopharmaceutical company, today announced that Sosei Co., Ltd., its wholly owned Japanese subsidiary, was granted approval for its emergency contraceptive pill, NorLevo(R) TABLETS 0.75mg, by the Japan Ministry of Health, Labour and Welfare (MHLW). NorLevo(R) has thus become the fist emergency contraceptive pill available in Japan.

23 Feb 2011

WomanCare Global expands product portfolio to include Roselle, Optinor

WomanCare Global is pleased to announce an expansion of their global product portfolio to include Roselle, a combined oral contraceptive (COC) pill containing 150 micrograms of levonorgestrel and 30 micrograms of ethinylestradiol and Optinor, a progesterone-only emergency contraception pill (ECP) containing 750 micrograms of levonorgestrel.

29 Nov 2010

Agile presents AG200-15 contraceptive patch Phase 2 clinical study results at 66th ASRM

Agile Therapeutics announced results today from a Phase 2 clinical study of AG200-15, Agile's weekly contraceptive patch containing ethinyl estradiol (EE) in combination with levonorgestrel (LNG). According to the clinical findings, AG200-15 provides a low daily dose of estrogen equivalent to 30 micrograms EE, similar to that in low-dose, oral contraceptive (OC) pills.

26 Oct 2010

Intrauterine devices for treatment of endometrial cancer

Intrauterine devices, originally developed as contraceptives, can also be used to treat and cure cancer of the endometrium according to new research published online in the cancer journal, Annals of Oncology today (Wednesday 29 September). The finding opens the way for young women with the disease, which affects the lining of the womb, to be treated without the need for a hysterectomy, thus preserving their fertility until they have had all the children they want.

29 Sep 2010

Watson to launch ella emergency contraceptive in fourth-quarter 2010

Watson Pharmaceuticals, Inc., today announced that it intends to launch ella® (ulipristal acetate), a novel oral emergency contraceptive, in the fourth quarter of 2010. Watson's announcement follows the approval of ella® by the FDA as safe and effective in preventing unintended pregnancy for up to 120 hours – or five days – post-unprotected intercourse (UPI) or contraceptive failure.

16 Aug 2010

FDA approves ellaOne for emergency contraception

HRA Pharma announced today that the US Food and Drug Administration (FDA) granted approval for ella(R) (ulipristal acetate) as a prescription-only emergency contraceptive indicated for use within 120 hours (five days) of unprotected intercourse or a known or suspected contraceptive failure. ella is not intended for routine use as a contraceptive.

16 Aug 2010

Agile initiates Phase 3 NEW CHOICE Study of AG200-15 contraceptive patch

Agile Therapeutics, Inc., a pharmaceutical development company specializing in women's healthcare products, today announced study initiation and dosing of the first patient in the Company's pivotal, Phase 3 NEW CHOICE Study of AG200-15, Agile's lead contraceptive patch. AG200-15 is designed to effectively deliver a low dose of estrogen in combination with levonorgestrel. The patch is applied once weekly for three weeks followed by a patch-free week.

11 Aug 2010

Agile Therapeutics completes $45 million Series B Preferred Stock financing round

Agile Therapeutics, Inc., a late-stage pharmaceutical company specializing in women's healthcare products, today announced that it completed a $45 million Series B Preferred Stock financing. The financing round was co-led by Investor Growth Capital and Care Capital, with strong participation from ProQuest Investments. Kaiser Permanente Ventures and Novitas Capital also joined the financing round. Investor Growth Capital, Care Capital, and Kaiser Permanente Ventures are new investors to Agile.

14 Jun 2010

Watson Pharmaceuticals reaches patent litigation settlement with Teva Women's Health

Watson Pharmaceuticals, Inc. today announced that its subsidiary, Watson Laboratories, Inc. has reached a settlement with Teva Women's Health, Inc. on outstanding patent litigation related to Teva's Seasonale® (levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/0.03 mg) product.

10 May 2010

Traces of many medicines found in fish swimming in treated waste water

Researchers at Ume- University and the Sahlgrenska Academy at the University of Gothenburg, Sweden, have discovered that traces of many medicines can be found in fish that have been swimming in treated waste water. One such medicine, the hormone levonorgestrel, was found in higher concentrations in the blood of fish than in women who take the contraceptive pill. Elevated levels of this hormone can lead to infertility in fish.

5 Apr 2010

Watson Pharmaceuticals files ANDA with FDA seeking approval to market LoSeasonique

Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc., has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its levonorgestrel and ethinyl estradiol (0.10 mg/0.02 mg) oral contraceptive product prior to the expiration of U.S. Patent No. 7,615,545, which is owned by Duramed Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceutical Industries, Ltd.

9 Jan 2010

Sosei and ASKA Pharmaceuticals sign distribution agreement

Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565), the biopharmaceutical company, today announced that Sosei Co., Ltd., its wholly owned Japanese subsidiary, has entered into a definitive distribution agreement with ASKA Pharmaceuticals Co., Ltd. ("ASKA", TSE First Section Index: 4514) for the commercialisation of the emergency contraceptive pill SOH-075 (NorLevo(R)).

2 Nov 2009

FDA approves Bayer's IUD Mirena for treating heavy menstrual bleeding

The U.S. Food and Drug Administration today approved Mirena (levonorgestrel intrauterine system) to treat heavy menstrual bleeding in women who use intrauterine contraception as their method of pregnancy prevention. This is the first intrauterine device approved by the FDA for this additional indication.

3 Oct 2009

HRA Pharma launches its new generation emergency contraceptive in Europe

HRA Pharma (http://www.hra-pharma.com), a privately-held, European pharmaceutical company that designs products, devices and supporting services in reproductive health and endocrinology, announced today that ellaOne(R) (ulipristal acetate, 30mg), its new generation emergency contraceptive, has been launched in France, Germany and the United Kingdom via local HRA teams. HRA Pharma will progressively launch ellaOne in all European countries over the coming months.

1 Oct 2009

Teva announces availability of its Plan B One-Step emergency contraceptive over-the-counter

Teva Women’s Health, Inc. announced today that its Plan B® One-Step (levonorgestrel) tablet, 1.5 mg emergency contraceptive is now available at licensed U.S. retail pharmacies. Approved by the U.S. Food and Drug Administration (FDA) on July 10, Plan B® One-Step can help prevent an unintended pregnancy after unprotected sex or contraceptive failure with just one pill in one dose.

16 Sep 2009

FDA approves Watson Pharmaceuticals' ANDA for Levonorgestrel tablets

Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today announced that its subsidiary, Watson Laboratories, Inc., has received approval today from the United States Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Levonorgestrel Tablets, 0.75 mg for over-the-counter use in women ages 17 and above, as well as for prescription use in women under the age of 17.

29 Aug 2009