Navigation Links
FDA Approves Duramed's LoSEASONIQUE(R) Oral Contraceptive
Date:10/27/2008

Duramed to Launch First Lower-Dose, Extended-Cycle Oral Contraceptive for the Prevention of Pregnancy

MONTVALE, N.J., Oct. 27 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that the U.S. Food and Drug Administration (FDA) has approved its subsidiary Duramed Pharmaceuticals, Inc.'s New Drug Application (NDA) for LoSEASONIQUE(R) (levonorgestrel/ethinyl estradiol tablets 0.10 mg/0.02 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptive. LoSEASONIQUE(R) is the first lower-dose, extended-cycle oral contraceptive indicated for the prevention of pregnancy.

Under the LoSEASONIQUE(R) extended-cycle regimen, women take combination tablets containing 0.10 mg levonorgestrel/0.02 mg of ethinyl estradiol daily for 84 consecutive days, followed 0.01 mg ethinyl estradiol tablets for seven days. The regimen is designed to reduce the number of withdrawal bleeding periods from 13 to four per year. By contrast, the majority of oral contraceptive products currently available in the United States are based on a regimen of 21 treatment days, followed by seven days of placebo.

LoSEASONIQUE(R) will be shipped to trade customers and available by prescription to women in the first quarter of 2009. Duramed will initiate promotion to healthcare providers in early 2009 using its sales force and other marketing initiatives.

"As a leader in women's health, Duramed is committed to continuing to develop new products that provide women a choice as they discuss birth control options with their healthcare providers," said Fred Wilkinson, Duramed's Chief Executive Officer. "We're pleased that the FDA has approved LoSEASONIQUE(R) as a safe, effective new birth control option for U.S. women." '/>"/>

SOURCE Barr Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related biology technology :

1. FDA Approves Astellas Vaprisol(R) (Conivaptan Hydrochloride Injection) Premixed in 5% Dextrose for the Treatment of Hyponatremia
2. FDA Approves Orphan Drug Status for Revolutionary Cancer Drug for Children
3. FDA Approves AstraZenecas SEROQUEL XR(R) for the Treatment of Bipolar Depression and Bipolar Mania
4. FDA Approves Fougeras Clotrimazole Cream USP 1%
5. FDA Approves ALOXI(R) (Palonosetron HCl) Capsules for Prevention of Acute Chemotherapy-induced Nausea and Vomiting
6. USDA Approves Syngenta and John Deere for Broadened Biotechnology Endorsement for Corn Crop Insurance
7. Signalife Board Approves Merger
8. FDA Approves EOVIST(R) to Detect and Characterize Focal Liver Lesions
9. FDA Approves Abbotts XIENCE(TM) V Drug Eluting Stent
10. FDA Approves ACIPHEX(R) (rabeprazole sodium) 20 mg for Short-Term Treatment of GERD in Adolescents
11. FDA Approves CONCERTA(R) (methylphenidate HCI) Extended-release Tablets for Treatment of ADHD (Attention Deficit Hyperactivity Disorder) in Adults
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/30/2014)... CA (PRWEB) July 30, 2014 ... from the U.S. Environmental Protection Agency (EPA). This ... in developmental toxicity models, including tests designed to ... formation and the formation of connections between neurons ... of neurodifferentiation and synapse formation by environmental pollutants ...
(Date:7/30/2014)... Immunology Summit-2014 will ... Investigators, scientists in the field, which includes prominent ... Case Western Reserve University School of Medicine, USA, ... “The effects of recombinant human IL-6 and ... Arya Biragyn, a Senior investigator at National Institute ...
(Date:7/29/2014)... (PRWEB) July 30, 2014 ... and collaboration company, is proud to announce the ... management positions in their Boston, Charleston and Atlanta ... to the increased demand for hosted solutions, collaboration ... efficiency and reduce cost. , SoundConnect was founded ...
(Date:7/29/2014)... NASA technologists have hurdled a number of significant ... already revolutionary observing technology originally created for the ... by Principal Investigator Harvey Moseley, a scientist at ... has demonstrated that electrostatically actuated microshutter arrays ... voltage are as functional as the current ...
Breaking Biology Technology:U.S. Environmental Protection Agency (EPA) Awards Vala Sciences a Second ToxCast Contract 2U.S. Environmental Protection Agency (EPA) Awards Vala Sciences a Second ToxCast Contract 3Unveiling Breakthroughs in Clinical & Cellular Immunology 2Unveiling Breakthroughs in Clinical & Cellular Immunology 3SoundConnect Organization and Culture is Evolving 2Revolutionary microshutter technology hurdles significant challenges 2Revolutionary microshutter technology hurdles significant challenges 3Revolutionary microshutter technology hurdles significant challenges 4
... molecules in a living cell is something that has long ... diamond, may well be able to do this and potentially ... for, hard-to-cure diseases such as cancer. In a ... Physics and the German Physical Society,s New Journal of ...
... & Co. Inc., a unit of Oppenheimer Holdings, is pleased ... as Managing Director in the Healthcare group of the Firm,s ... science business. He will report to Brian McCarthy, Managing Director ... 2003, Matthias had worked at JMP Securities, where he was ...
... FREMONT, Calif., May 18, 2011 Biomerix Corporation and ... Biomerix 3D Scaffold , a novel three-dimensional tissue ... the Biomerix 3D Scaffold to research institutions across Europe. ... polycarbonate polyurethane , the Biomerix 3D Scaffold is ...
Cached Biology Technology:'Critical baby step' taken for spying life on a molecular scale 2Biomerix Corporation Reaches European Distribution Agreement with Cellon S.A. 2
(Date:7/30/2014)... shrinking ranges and a changing climate threaten some ... plants, and so conservationists establish seed collections to ... in hopes of preserving some genetic diversity., For ... simple models that offer a one-size-fits-all approach for ... saving 50 seed samples regardless of species, pollination ...
(Date:7/30/2014)... Americans make better decisions about what they eat, the ... significant changes to the Nutrition Facts label found on ... in Chemical & Engineering News (C&EN), the ... the suggested updates and the fight that has ... points out that while the Nutrition Facts label has ...
(Date:7/30/2014)... of Engineering recently received a $330,000 award from ... synthesis of organic nanorods." , According to ... and utilization of functional materials, devices, and systems ... in scaling up nanotechnology is the lack of ... one device. A research team led by Dr. ...
Breaking Biology News(10 mins):Saving seeds the right way can save the world's plants 2NSF grant to Wayne State supports new concept for manufacturing nanoscale devices 2
... ago, a tiny mayfly had a problem. Like most adult mayflies, ... no time to waste. She took her mating flight, got fertilized, and ... got stuck in some oozing tree sap and died, preserved for all ... It was a pretty rude ending to what was already going to ...
... COLUMBUS, Ohio Astronomers, research on celestial bodies ... Ohio State University astronomers are working with medical physicists ... treatment one that is intended to be tougher ... studying how chemical elements emit and absorb radiation inside ...
... Wiley of the National Oceanic and Atmospheric Administration (NOAA) and ... (Volume 148, Nos. 5-6) how humpback whales in the Gulf ... ( Megaptera novaeangliae ) are large baleen whales (up to ... dense concentrations, such as krill or herrings. Humpbacks ...
Cached Biology News:Ancient species of mayfly had short, tragic life 2Astronomers reach for the stars to discover new cancer therapy 2Astronomers reach for the stars to discover new cancer therapy 3Astronomers reach for the stars to discover new cancer therapy 4Humpback whales catch prey with bubble-nets 2
... The LTQ XL extends the legendary ... techniques to generate structural information through Thermo ... Thermo Scientific's LTQ XL is the only ... PQD, ETD and CID. Pulsed Q ...
... Varian, Inc.'s CP-4900 is a ... always delivers the information you ... When the composition of gas ... generation micro-Gas Chromatograph generates more ...
... The PolarScreen Peroxisome Proliferator-Activated Receptor-gamma ... a sensitive and efficient method ... PPARGamma ligands using fluorescence polarization ... PPARGamma-Ligand binding domain (PPARGamma-LBD) with ...
The essence of fluorescence analysis is sensitivity. The high throughput optical system in the RF-5301PC employs a blazed holographic grating, photomultiplier and digital signal processing to provide...
Biology Products: