Content about Levonorgestrel

June 11, 2013
Emergency contraceptive Plan B One Step now on course to be available OTC without any sales restrictions

The emergency contraceptive Plan B (the original two-tablet formulation) can now be sold as an OTC without any sales restrictions as the Obama administration concedes its fight to prevent nonprescription access to younger teenage girls. And soon the newer Plan B One Step (one tablet) will be available without sales restrictions as well.

May 30, 2013
Plan B heads toward family-planning aisle

The Food and Drug Administration last month announced that it has approved an amended application submitted by Teva Women's Health to market Plan B One-Step (levonorgestrel) for use without a prescription by women 15 years of age and older. That approval moved Plan B One-Step from behind the pharmacy counter into the family planning section of the pharmacy.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

January 7, 2011
Sandoz contraceptive granted regulatory approval

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

November 29, 2010
WomenCare Global buys two oral contraceptive brands

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

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...

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