Content about Emergency contraception

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 2, 2013

The Justice Department reported it will appeal a recent judicial decision that would require removing any age restriction from the purchase of the Plan B emergency contraceptive, according to a report published in USA Today.

WASHINGTON — The Justice Department late Wednesday reported it will appeal a recent judicial decision that would require removing any age restriction from the purchase of the Plan B emergency contraceptive, according to a report published in USA Today.

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. 

April 5, 2013

The Food and Drug Administration has 30 days to approve over-the-counter availability of the emergency contraceptive Plan B One-Step to women of all ages, according to a decision issued by Judge Edward Korman of the U.S. District Court, Eastern District of New York.

NEW YORK — The Food and Drug Administration has 30 days to approve over-the-counter availability of the emergency contraceptive Plan B One-Step to women of all ages, according to a decision issued Friday by Judge Edward Korman of the United States District Court, Eastern District of New York. In a second decision, Korman declined to intervene on Teva Pharma's behalf in extending patent exclusivity for Plan B One-Step. 

April 5, 2013

The American Academy of Pediatrics, the American College of Obstetricians and Gynecologists and the Society of Adolescent Health and Medicine Friday morning commended a U.S. District Court ruling that expands over-the-counter access of Plan B One-Step to women under the age of 17.

WASHINGTON — The American Academy of Pediatrics, the American College of Obstetricians and Gynecologists and the Society of Adolescent Health and Medicine Friday morning commended a U.S. District Court ruling that expands over-the-counter access of Plan B One-Step to women under the age of 17. "This decision reflects the overwhelming evidence that emergency contraception is safe and effective for all women of reproductive age," the medical associations stated as part of a joint statement. 

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. 

July 30, 2012

The Food and Drug Administration has approved Watson Pharmaceuticals’ Next Choice One Dose (levonorgestrel) tablets in the 1.5-mg strength.

SUPPLIER NEWS — The Food and Drug Administration has approved Watson Pharmaceuticals’ 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. It 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.


July 13, 2012

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.

April 13, 2012

Get set for another decade of explosive growth throughout the over-the-counter category with the familiar switch as a catalyst. 


Get set for another decade of explosive growth throughout the over-the-counter category with the familiar switch as a catalyst. 


The Food and Drug Administration public meeting that took place last month addressed a proposal to expand the switch paradigm by utilizing the latest in communications and diagnostics technology and/or incorporating the most accessible healthcare professional — the retail pharmacist — into the self-care decision protocol. 


March 27, 2012

Pharmacies may be misinforming teenagers about where they can locate emergency contraceptives without a prescription, according to a new study published in Pediatrics.

NEW YORK — Pharmacies may be misinforming teenagers about where they can locate emergency contraceptives without a prescription, according to a new study published in Pediatrics.

February 9, 2012

The Center for Reproductive Rights on Wednesday asked a federal court to reopen its 2005 lawsuit against the Food and Drug Administration for imposing age restrictions on emergency contraceptive drugs.

NEW YORK — The Center for Reproductive Rights on Wednesday asked a federal court to reopen its 2005 lawsuit against the Food and Drug Administration for imposing age restrictions on emergency contraceptive drugs. Presently, emergency contraceptives, like Plan B One Step, are available behind a pharmacy counter for women 17 years and older but require a prescription for women under the age of 17 years.

December 9, 2011

"I am appalled that politics has once again trumped science," wrote Brooklyn College Health Clinic director and nurse practitioner Ilene Tannenbaum in a letter to the New York Times. That reaction summed up much of the medical community's response to the Department of Health and Human Services' overruling of the Food and Drug Administration's decision to make the Plan B contraceptive pill a full nonprescription product.

WHAT IT MEANS AND WHY IT’S IMPORTANT — "I am appalled that politics has once again trumped science," wrote Brooklyn College Health Clinic director and nurse practitioner Ilene Tannenbaum in a letter to the New York Times. That reaction summed up much of the medical community's response to the Department of Health and Human Services' overruling of the Food and Drug Administration's decision to make the Plan B contraceptive pill a full nonprescription product.

December 8, 2011

A group of medical associations on Wednesday denounced the government's decision to maintain the status quo with regard to the prescription status of the emergency contraceptive Plan B.

WASHINGTON — A group of medical associations on Wednesday denounced the government's decision to maintain the status quo with regard to the prescription status of the emergency contraceptive Plan B.

December 7, 2011

Food and Drug Administration commissioner Margaret Hamburg on Wednesday issued a public statement that the agency was prepared to approve Plan B as a nonprescription medication, but reversed that decision following a directive from the Department of Health and Human Services Wednesday morning.

SILVER SPRING, Md. — Food and Drug Administration commissioner Margaret Hamburg on Wednesday issued a public statement that the agency was prepared to approve Plan B as a nonprescription medication, but reversed that decision following a directive from the Department of Health and Human Services Wednesday morning.

December 7, 2011

The Department of Health and Human Services on Wednesday denied a request made by Teva Pharmaceuticals to relax merchandising restrictions for the emergency contraceptive Plan B.

WASHINGTON — The Department of Health and Human Services on Wednesday denied a request made by Teva Pharmaceuticals to relax merchandising restrictions for the emergency contraceptive Plan B. Presently, Plan B can be sold without a prescription to women older than 17 years old but only in a pharmacy and from behind the pharmacy counter. Women younger than 17 years require a prescription to acquire Plan B.

December 6, 2011

The Food and Drug Administration will decide on Wednesday whether to remove merchandising restrictions on the emergency contraceptive Plan B and allow the product to be merchandised in the front-end without age restrictions, according to a report published Monday in the Washington Post.

WASHINGTON — The Food and Drug Administration will decide on Wednesday whether to remove merchandising restrictions on the emergency contraceptive Plan B and allow the product to be merchandised in the front-end without age restrictions, according to a report published Monday in the Washington Post.

August 2, 2011

The Food and Drug Administration on Friday warned U.S. consumers not to use the emergency birth control medicine labeled as Evital, as it may be a counterfeit version of the “morning after pill” and may not be safe or effective in preventing pregnancy.

SILVER SPRING, Md. — The Food and Drug Administration on Friday warned U.S. consumers not to use the emergency birth control medicine labeled as Evital, as it may be a counterfeit version of the “morning after pill” and may not be safe or effective in preventing pregnancy.
 
In addition, no brand labeled Evital has been approved by the FDA for use in the United States.

April 7, 2011

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.

February 11, 2011

Teva earlier this week announced it had submitted a request to the Food and Drug Administration to allow for the sale of the emergency contraceptive Plan B One-Step to women under the age of 17 years without a prescription, according to published reports.

NORTH WALES, Pa. — Teva earlier this week announced it had submitted a request to the Food and Drug Administration to allow for the sale of the emergency contraceptive Plan B One-Step to women under the age of 17 years without a prescription, according to published reports.

December 1, 2010

Drug maker Watson Pharmaceuticals has made an emergency oral contraceptive available by prescription in the United States, the company said Wednesday.

MORRISTOWN, N.J. — Drug maker Watson Pharmaceuticals has made an emergency oral contraceptive available by prescription in the United States, the company said Wednesday.

Watson announced the launch of Ella (ulipristal acetate) in the 30-mg dose, designed to prevent pregnancy up to five days after unprotected sex or failure of other contraceptives. The drug is designed to delay ovulation for five days, the amount of time that sperm can survive in the female genital tract.

November 10, 2010

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

August 15, 2010

The Food and Drug Administration has approved an emergency contraceptive pill made by a French...

SILVER SPRING, Md. The Food and Drug Administration has approved an emergency contraceptive pill made by a French drug maker.

 

The FDA announced the approval of Ella (ulipristal acetate), designed to prevent pregnancy when taken orally within five days of unprotected sex or contraceptive failure, though it is not designed for routine use as a contraceptive.

 

 

June 30, 2010

The Washington Board of Pharmacy has initiated a rule-change process that would require pharmacists who...

May 6, 2010

The Food and Drug Administration has approved a new oral contraceptive made by Bayer, the...