Content about Emergency contraceptive availability by country

October 22, 2013

The Food and Drug Administration has approved a generic contraceptive drug made by Famy Care, agency records show.

SILVER SPRING, Md. — The Food and Drug Administration has approved a generic contraceptive drug made by Famy Care, agency records show.

The agency approved Famy's levonorgestrel and ethinyl estradiol tablets in the 0.02-mg/0.1-mg strengths.

The drug is a generic version of Aviane-28, made by Teva Women's Health, a division of Israeli drug maker Teva Pharmaceutical Industries that previously went under the name Duramed.

 

August 7, 2013

Teva Women’s Health, the U.S subsidiary of Teva Pharmaceuticals, announced on Wednesday that the emergency contraceptive Plan B One-Step (levonorgestrel) tablet 1.5 mg is now widely available at retail with no age or point-of-sale restrictions.

NORTH WALES, Pa. — Teva Women’s Health, the U.S subsidiary of Teva Pharmaceuticals, announced on Wednesday that the emergency contraceptive Plan B One-Step (levonorgestrel) tablet 1.5 mg is now widely available at retail with no age or point-of-sale restrictions. Plan B One-Step marks the first emergency contraceptive to be available for OTC sale to all consumers.

July 24, 2013

The Food and Drug Administration has granted the manufacturer of Plan B One-Step exclusive marketing rights for three years, according to published reports.

WASHINGTON — The Food and Drug Administration has granted the manufacturer of Plan B One-Step exclusive marketing rights for three years, according to published reports.

According to the New York Times, the decision by the FDA sets Teva Pharmaceuticals as the only company able to sell the drug over-the-counter and without a prescription to a person of any age.

June 21, 2013

The Food and Drug Administration has approved a contraceptive pill for all women of childbearing potential without a prescription, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a contraceptive pill for all women of childbearing potential without a prescription, the agency said.

The FDA said the new approval of Teva Women's Health's Plan B One-Step (levonorgestrel) was to comply with an April 5 federal court order to make emergency contraceptives containing levonorgestrel available over the counter without age or point-of-sale restrictions.

June 11, 2013

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.

NEW YORK — 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 13, 2013

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

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

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. 

February 14, 2013

Between 2006 and 2010, 1-in-9 sexually experienced women between the ages of 15 and 44 years had used emergency contraception at least once, the National Center for Health Statistics noted in a report released Wednesday.

ATLANTA — Between 2006 and 2010, 1-in-9 sexually experienced women between the ages of 15 and 44 years had used emergency contraception at least once, the National Center for Health Statistics noted in a report released Wednesday. Use of emergency contraception, such as Plan B One-Step, was the most common among women between the ages of 20 and 24 years, those who never married, Hispanic or non-Hispanic white women, and those who attended college. 

That compares with 2-in-5 women who used emergency contraception in 2002 and fewer than 1-in-10 women in 1995. 

December 28, 2012

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.

June 28, 2009

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.