Content about Emergency contraceptive availability by country

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. 

February 14, 2013
NCHS: OTC switch approval of Plan B broadened access to emergency contraception

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 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.

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.