Content about Hormonal contraception

April 17, 2014

Mylan announced the launch of Xulane (norelgestromin/ethinyl estradiol transdermal system 150/35-mcg per day), the generic version of Ortho Evra (norelgestromin/ethinyl estradiol transdermal system 150/35-mcg per day) from Janssen Pharmaceuticals.

PITTSBURGH — Mylan announced the launch of Xulane (norelgestromin/ethinyl estradiol transdermal system 150/35-mcg per day), the generic version of Ortho Evra (norelgestromin/ethinyl estradiol transdermal system 150/35-mcg per day) from Janssen Pharmaceuticals. The drug is used to prevent pregnancy in women who want to use a transdermal patch as a contraception method.

April 15, 2014

Actavis on Tuesday announced that it has entered into an agreement with Mylan and Famy Care to settle all outstanding patent litigation related to Mylan's generic version of Generess FE (norethindrone, ethinyl estradiol and ferrous fumarate chewable tablets).

DUBLIN — Actavis on Tuesday announced that it has entered into an agreement with Mylan and Famy Care to settle all outstanding patent litigation related to Mylan's generic version of Generess FE (norethindrone, ethinyl estradiol and ferrous fumarate chewable tablets).

Under the terms of the agreement, Actavis will grant Mylan a license to market its generic version of Generess FE under its pending abbreviated new drug application beginning on April 1, 2015.

March 3, 2014

The Food and Drug Administration last week ruled that generic equivalents to Teva Pharmaceutical's Plan B emergency contraceptive can be sold alongside Plan B without any behind-the-counter merchandising restrictions or a requirement to verify the age of the purchaser in a letter to the interested parties.

SILVER SPRING, Md. — The Food and Drug Administration last week ruled that generic equivalents to Teva Pharmaceutical's Plan B emergency contraceptive can be sold alongside Plan B without any behind-the-counter merchandising restrictions or a requirement to verify the age of the purchaser in a letter to the interested parties

January 21, 2014

Actavis confirmed that the U.S. District Court for the District of New Jersey found United States Patent No. 7,704,984 (the '984 Patent) to be valid and infringed by Lupin Pharmaceuticals and Amneal Pharmaceuticals Abbreviated New Drug Applications (ANDAs) for generic versions of Actavis' Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets).

DUBLIN — Actavis last week confirmed that the U.S. District Court for the District of New Jersey found United States Patent No. 7,704,984 (the '984 Patent) to be valid and infringed by Lupin Pharmaceuticals and Amneal Pharmaceuticals Abbreviated New Drug Applications (ANDAs) for generic versions of Actavis' Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets).  

Lo Loestrin Fe is a prescription birth control pill used for the prevention of pregnancy.

December 26, 2013

The Food and Drug Administration declined to approve an experimental contraceptive patch developed by Actavis, the drug maker said Tuesday.

DUBLIN — The Food and Drug Administration declined to approve an experimental contraceptive patch developed by Actavis, the drug maker said Tuesday.

Actavis said the FDA sent it a complete response letter for its progestin-only transdermal contraceptive patch. A complete response letter means that the agency has finished reviewing a drug-approval application, but questions remain that preclude final approval.

December 26, 2013

Actavis said it was likely the first company to file with the Food and Drug Administration for approval of a generic version of a contraceptive device made by Merck, the generic drug maker said Tuesday.

DUBLIN — Actavis said it was likely the first company to file with the Food and Drug Administration for approval of a generic version of a contraceptive device made by Merck, the generic drug maker said Tuesday.

Actavis said Warner Chilcott, now one of its subsidiaries, had filed with the FDA for approval of the ethinyl estradiol and etonogestrel vaginal ring in the 0.015-mg-per-day and 0.12-mg-per-day strengths. The device is a generic version of Merck's NuvaRing.

December 26, 2013

Sales of OTC female contraceptives ought to be significant in the coming year.

Sales of OTC female contraceptives ought to be significant in the coming year. Already, the category is up 2.3% to $232.7 million, and that number is expected to go up now that the Food and Drug Administration has approved Teva Women’s Health’s Plan B One-Step (levonorgestrel) without a prescription.

December 26, 2013

Actavis last year gained approval for its Next Choice, a generic version of Teva Women’s Health’s Plan B One-Step, that now sits on top in emergency contraceptive sales.

PARSIPPANY, N.J. — Actavis last year gained approval for its Next Choice, a generic version of Teva Women’s Health’s Plan B One-Step, that now sits on top in emergency contraceptive sales. For the 52 weeks ended Oct. 6, Next Choice generated $115.2 million fueled by 20.2% growth. Plan B One-Step is ranked No. 2 with $96.4 million in sales, down 10.7%. Earlier this year, the FDA increased access to emergency contraceptives by no longer requiring that they be placed behind the pharmacy counter.

November 26, 2013

The Food and Drug Administration is reviewing emergency contraceptives like Plan B One-Step on whether they are less effective in women weighing more than 165 lbs, according to a report published Monday by Reuters.

NEW YORK — The Food and Drug Administration is reviewing emergency contraceptives like Plan B One-Step on whether they are less effective in women weighing more than 165 lbs., according to a report published Monday by Reuters

November 8, 2013

Generic drug maker Amneal Pharmaceuticals will launch its version of a contraceptive product at the beginning of January, the drug maker said.

BRIDGEWATER, N.J. — Generic drug maker Amneal Pharmaceuticals will launch its version of a contraceptive product at the beginning of January, the drug maker said.

Amneal said it would launch its version of 24 Fe (norethindrone acetate and ethinyl estradiol tablets; ferrous fumarate tablets) in the 1 mg/20 mcg and 75 mg strength. As the first company to successfully file for Food and Drug Administration approval of the drug, Amneal's product will have 180 days in which to compete exclusively against the branded version.

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.

 

September 30, 2013

Amneal Pharmaceuticals has bought rights to four generic drugs from Actavis, Amneal said Monday.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has bought rights to four generic drugs from Actavis, Amneal said Monday.

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.

July 16, 2013

Mylan has launched a generic contraceptive therapy, the drug maker said Tuesday.

PITTSBURGH — Mylan has launched a generic contraceptive therapy, the drug maker said Tuesday.

Mylan, through its Mylan Pharmaceuticals subsidiary, announced the launch of norethindrone tablets in the 0.35-mg strength. The drug is a generic version of Actavis' Nor-Q.D. tablets, which are taken on a 28-day cycle to prevent pregnancy. Mylan is partnering with Famy Care, which filed for and received Food and Drug Administration approval for the drug.

June 26, 2013

Mylan has launched a generic version of a Johnson & Johnson contraceptive, the company said Wednesday.

PITTSBURGH — Mylan has launched a generic version of a Johnson & Johnson contraceptive, the company said Wednesday.

Mylan announced the launch of norethindrone tablets in the 0.35 mg strength. The drug is a generic version of Micronor, made by J&J subsidiary Janssen Pharmaceuticals. A company partnering with Mylan on the drug, Famy Care, received approval from the Food and Drug Administration for the drug.

Various versions of the drug had sales of about $57.2 million during the 12-month period that ended in March, according to IMS Health.

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 30, 2013

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.

SILVER SPRING, Md. — 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 14, 2013

The Food and Drug Administration will review an experimental contraceptive patch made by Actavis, the drug maker said Tuesday.

PARSIPPANY, N.J. — The Food and Drug Administration will review an experimental contraceptive patch made by Actavis, the drug maker said Tuesday.

Actavis said the FDA accepted for review its application for norethindrone transdermal delivery system. The patch, which does not yet have a brand name, is designed to provide continuous delivery of norethindrone during a once-weekly, seven-day dosing regimen.

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 3, 2013

Women who take low-dose oral contraceptives may be at increased risk of chronic pelvic-pain symptoms and pain during sexual climax, according to a new study.

SAN DIEGO — Women who take low-dose oral contraceptives may be at increased risk of chronic pelvic-pain symptoms and pain during sexual climax, according to a new study.

The study, scheduled for presentation to reporters at the American Urological Association's annual scientific meeting in San Diego on Tuesday, was conducted by researchers at New York University and the Waitemata District Health Board in Auckland, New Zealand, compared CPPS in young women who used oral contraceptives with the condition in those who didn't.

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.