Content about Levonorgestrel

May 13, 2013
Temporary stay of Plan B decision extended through May 28

The Food and Drug Administration's temporary stay pending its appeal of a district court decision ordering all levonorgestrel-based emergency contraceptives be available without a prescription and without any age restrictions was extended through May 28 by the U.S. Court of Appeals for the Second Circuit.

NEW YORK — The Food and Drug Administration's temporary stay pending its appeal of a district court decision ordering all levonorgestrel-based emergency contraceptives be available without a prescription and without any age restrictions was extended through May 28 by the U.S. Court of Appeals for the Second Circuit on Monday. 

The Second Circuit will entertain the appeal on that day. 

May 10, 2013
FDA must file Plan B appeal by noon on May 13 or remove age restrictions from all OTC EC products

Senior U.S. District Judge Edward Korman on Friday denied a Food and Drug Administration motion for a stay pending an appeal of Korman's earlier decision that all levonorgestrel-based emergency contraceptives be available without a prescription and without any age restrictions.

NEW YORK — Senior U.S. District Judge Edward Korman on Friday denied a Food and Drug Administration motion for a stay pending an appeal of Korman's earlier decision that all levonorgestrel-based emergency contraceptives be available without a prescription and without any age restrictions. 

However, Korman did grant a stay "pending the hearing or submission of the defendants’ motion for a stay in the Court of Appeals on the condition that the motion for a stay be filed by noon on May 13, 2013."

May 1, 2013
FDA approves Plan B One-Step front-end placement for females 15 and older

The Food and Drug Administration announced that it has approved an amended application submitted by Teva Women’s Health to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years and older.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday announced that it has approved an amended application submitted by Teva Women’s Health to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years and older. The approval will move Plan B from behind the pharmacy counter into the family planning set of the pharmacy. 

April 12, 2013
FDA approves Lupin generic contraceptive

The Food and Drug Administration has approved a contraceptive therapy made by Lupin Pharmaceuticals, the Indian drug maker said Friday.

MUMBAI, India — The Food and Drug Administration has approved a contraceptive therapy made by Lupin Pharmaceuticals, the Indian drug maker said Friday.

Lupin announced the approval of Daysee (levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets) in the 0.15-mg/0.03-mg and 0.01-mg strengths.

The drug is a generic version of Teva's Seasonique. Various versions of the drug had sales of $161 million in 2012, according to IMS Health.

 

April 1, 2013
FDA approves new Teva contraceptive

The Food and Drug Administration has approved a new contraceptive therapy made by Teva Pharmaceutical Industries, Teva said Monday.

JERUSALEM — The Food and Drug Administration has approved a new contraceptive therapy made by Teva Pharmaceutical Industries, Teva said Monday.

The drug maker announced the approval of Quartette (levonorgestrel, ethinyl estradiol and ethinyl estradiol) tablets. Teva said the drug represented the "next generation" of extended-regimen oral contraceptives and was designed to minimize breakthrough bleeding between scheduled periods.

January 22, 2013
FDA approves Lupin contraceptive

The Food and Drug Administration has approved a generic contraceptive made by Lupin Pharmaceuticals, the drug maker said Tuesday.

BALTIMORE — The Food and Drug Administration has approved a generic contraceptive made by Lupin Pharmaceuticals, the drug maker said Tuesday.

Lupin announced the approval of levonorgestrel and ethinyl estradiol tablets in the 0.1 mg/0.02 mg strength, a generic version of Watson Labs' Lutera.

Lutera had sales of about $103.6 million during the 12-month period that ended in September 2012, according to IMS Health.

January 10, 2013
FDA approves Bayer IUD

The Food and Drug Administration has approved a new intrauterine device for preventing pregnancy made by Bayer HealthCare Pharmaceuticals, the drug maker said.

WAYNE, N.J. — The Food and Drug Administration has approved a new intrauterine device for preventing pregnancy made by Bayer HealthCare Pharmaceuticals, the drug maker said.

Bayer announced the approval of Skyla (levonorgestrel-releasing uterine system), which can prevent pregnancy for up to three years. The IUD contains 13.5 mg of levonorgestrel.

Nearly 50% of pregnancies in the United States are unintended, according to the National Center for Health Statistics.

December 28, 2012
Mylan launches new generic oral contraceptive

Mylan on Friday announced that its partner Famy Care has received final approval from the Food and Drug Administration for its abbreviated new drug application for levonorgestrel and ethinyl estradiol Tablets USP in the 0.15mg/0.03mg strength.

PITTSBURGH — Mylan on Friday announced that its partner Famy Care has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for levonorgestrel and ethinyl estradiol tablets USP in the 0.15mg/0.03mg strength.

The product is a generic version of Teva Branded Pharmaceutical Products' Nordette 28 Tablets, a form of oral contraception. The new product will be distributed in the United States by Mylan Pharmaceuticals, and the company is shipping the product immediately.

October 18, 2012
FDA approves generic Lupin contraceptive

The Food and Drug Administration has approved a generic contraceptive made by Indian drug maker Lupin, the company said Thursday.

MUMBAI, India — The Food and Drug Administration has approved a generic contraceptive made by Indian drug maker Lupin, the company said Thursday.

Lupin announced the approval of Kurvelo (levonorgestrel and ethinyl estradiol) tablets in the 0.15 mg/0.03 mg strength.

The drug is a generic version of Teva's branded Nordette. Nordette had sales of about $59 million during the 12-month period ended in June, according to IMS Health.

August 13, 2012
FDA accepts Teva contraceptive pill application

The Food and Drug Administration is reviewing a regulatory application from Teva for a contraceptive drug, the company said Monday.

FRAZER, Pa. — The Food and Drug Administration is reviewing a regulatory application from Teva for a contraceptive drug, the company said Monday.

Teva Women's Health, part of Israeli drug maker Teva Pharmaceutical Industries, announced the FDA's acceptance of its application for Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol), which the company called the first ascending-dose, extended regimen oral contraceptive for preventing pregnancy.

July 13, 2012
FDA approves generic emergency contraceptive

The Food and Drug Administration has approved a generic contraceptive made by Watson Pharmaceuticals, the drug maker said Friday.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic contraceptive made by Watson Pharmaceuticals, the drug maker said Friday.

Watson announced the approval of Next Choice One Dose (levonorgestrel) tablets in the 1.5-mg strength. The drug is an emergency contraceptive used to prevent pregnancy following unprotected sex or contraceptive failure.

The drug is a generic version of Teva Women's Health's Plan B One-Step, which had sales of about $88 million during the 12-month period ended in March, according to IMS Health.

November 11, 2011
Appeals court rejects Teva request to stop Watson from selling generic Seasonique

An appeals court has thrown out an attempt by Teva Pharmaceutical Industries to stop Watson Pharmaceuticals from selling a generic contraceptive, Watson said.

PARSIPPANY, N.J. — An appeals court has thrown out an attempt by Teva Pharmaceutical Industries to stop Watson Pharmaceuticals from selling a generic contraceptive, Watson said.

The U.S. Court of Appeals for the Federal Circuit affirmed a lower court's June 16 decision to deny Duramed Pharmaceuticals' request for an injunction that would stop Watson from selling a generic version of Seasonique (levonorgestrel and ethinyl estradiol [0.15 mg/0.03 mg] and ethinyl estradiol [0.01 mg]). Duramed originally was a subsidiary of Barr Pharmaceuticals, which Teva acquired in 2008.

July 28, 2011
Watson launches generic Seasonique

Generic drug maker Watson Pharmaceuticals has launched a generic version of a contraceptive made by Duramed Pharmaceuticals, Watson said Thursday.

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals has launched a generic version of a contraceptive made by Duramed Pharmaceuticals, Watson said Thursday.

Watson announced the launch of Amethia (levonorgestrel and ethinyl estradiol [0.15 mg/0.03 mg] and ethinyl estradiol [0.01 mg]) after the U.S. Court of Appeals for the Federal Circuit denied Duramed’s request for a temporary injunction; a patent infringement lawsuit that Duramed filed against Watson remains pending.

June 17, 2011
FDA rejects Teva's request to block Watson's generic Seasonique

A federal court has rejected Teva Pharmaceutical Industries’ efforts to prevent Watson from launching a generic version of one of its drugs, Watson said Friday.

PARSIPPANY, N.J. — A federal court has rejected Teva Pharmaceutical Industries’ efforts to prevent Watson from launching a generic version of one of its drugs, Watson said Friday.

The U.S. District Court for the District of Nevada denied Duramed Pharmaceuticals’ request for an injunction to keep Watson’s generic version of the contraceptive Seasonique (levonorgestrel and ethinyl estradiol 0.15 mg/0.03 mg) and ethinyl estradiol 0.01 mg from being launched.

Seasonique is made by Teva Women’s Health, the successor of Duramed.

June 7, 2011
Watson gets FDA nod for generic Lybrel

The Food and Drug Administration has approved a generic contraceptive made by Watson Pharmaceuticals, the company said Tuesday.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic contraceptive made by Watson Pharmaceuticals, the company said Tuesday.

Watson announced the approval of levonorgestrel and ethinyl estradiol tablets in the 0.09-mg/0.02-mg strength.

The drug is a generic version of Pfizer’s Lybrel, which had sales of slightly less than $12 million during the 12-month period that ended in April, according to IMS Health.

June 1, 2011
FDA to examine possible link between drospirenone, blood clots risk

The Food and Drug Administration is investigating a possible link between a class of birth control pills and a higher risk of blood clots in the women taking them, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration is investigating a possible link between a class of birth control pills and a higher risk of blood clots in the women taking them, the agency said.

May 4, 2011
Sandoz gets OK for generic Yaz

The Food and Drug Administration has approved a generic oral contraceptive made by Sandoz, the generics arm of Swiss drug maker Novartis said Wednesday.

PRINCETON, N.J. — The Food and Drug Administration has approved a generic oral contraceptive made by Sandoz, the generics arm of Swiss drug maker Novartis said Wednesday.

Sandoz announced the approval of Loryna (drospirenone 3 mg and ethinyl estradiol 0.02 mg) tablets, a generic version of Bayer HealthCare Pharmaceuticals’ Yaz.

April 11, 2011
Sandoz gets FDA nod for Altavera

The Food and Drug Administration has approved an oral contraceptive made by Sandoz, the company said Friday.

PRINCETON, N.J. — The Food and Drug Administration has approved an oral contraceptive made by Sandoz, the company said Friday.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of Altavera (levonorgestrel and ethinyl estradiol) tablets, a generic version of Duramed’s Nordette.

Branded and generic versions of Nordette had sales of about $57.4 million during the 12-month period ended in February, according to IMS Health.

April 7, 2011
Ruling: Illinois pharmacists can refuse to dispense Plan B

Illinois Circuit Judge John Belz on Tuesday ruled that Illinois pharmacists could refuse to dispense the emergency contraceptive Plan B, despite a 2005 edict that required pharmacists to dispense Plan B, regardless of their religious beliefs, according to published reports.

SPRINGFIELD, Ill. — Illinois Circuit Judge John Belz on Tuesday ruled that Illinois pharmacists could refuse to dispense the emergency contraceptive Plan B, despite a 2005 edict that required pharmacists to dispense Plan B, regardless of their religious beliefs, according to published reports.

January 7, 2011
Sandoz contraceptive granted regulatory approval

The Food and Drug Administration has approved a generic contraceptive made by Sandoz, the company said.

PRINCETON, N.J. — The Food and Drug Administration has approved a generic contraceptive made by Sandoz, the company said.

Sandoz, the generics arm of Swiss drug maker Novartis, announced the FDA approval of Introvale (levonorgestrel and ethinyl estradiol), a generic version of Duramed’s Seasonale.

Branded and generic versions of Seasonale had sales of around $91 million during the 12-month period ended in November, according to IMS Health.

November 29, 2010
WomenCare Global buys two oral contraceptive brands

WomenCare Global has acquired two oral contraceptive brands from ICON, WomenCare said Monday.

CHAPEL HILL, N.C. — WomenCare Global has acquired two oral contraceptive brands from ICON, WomenCare said Monday.

The company acquired Roselle (levonorgestrel and ethinylestradiol) and Optinor (levonorgestrel). ICON developed both drugs under a partnership with an unnamed generic drug manufacturer.

“This partnership with WomenCare Global is a significant step forward in expanding access to quality-assured generic hormonal contraceptives at competitive prices,” ICON general manager David Smith said in a statement.

November 10, 2010
Teva Women's Health discusses emergency contraceptive at symposium

Nearly 1 million acts of unprotected sex take place in the United States every night....

January 31, 2010
Watson to become commercial partner for emergency contraceptive

Watson Pharmaceuticals and HRA Pharma have signed a deal whereby Watson will become the commercial...

January 7, 2010
Watson files FDA application for generic LoSeasonique

Watson Labs, a subsidiary of specialty pharmaceutical company Watson Pharmaceuticals, has filed an abbreviated new...

June 28, 2009
FDA approves generic contraceptive pill

The approval of Watson Pharmaceutical’s ANDA for levonorgestrel tablets, otherwise known as the emergency contraceptive...

NEW YORK The approval of Watson Pharmaceutical’s ANDA for levonorgestrel tablets, otherwise known as the emergency contraceptive Plan B, marks the first time a generic company gained prescription-only approval for one month, even as it awaits nonprescription approval for the same drug a few months down the line.

 

Of course, it’s fitting, as Plan B is the only medicine available as both a prescription and nonprescription remedy at the same strength and for the same indication, the only distinguishing factor being the age of the patient.