Content about Progestagens

January 27, 2014

Walgreens Infusion Services on Monday announced that it has been selected as the preferred provider of home administration services for Makena (hydroxyprogesterone caproate injection), the only FDA-approved medication to help reduce the risk of preterm birth for clinically indicated patients.

DEERFIELD, Ill. — Walgreens Infusion Services on Monday announced that it has been selected as the preferred provider of home administration services for Makena (hydroxyprogesterone caproate injection), the only FDA-approved medication to help reduce the risk of preterm birth for clinically indicated patients. Makena is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

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.

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 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.

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 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."

April 18, 2013

A federal court ruling has allowed Actavis to relaunch a generic contraceptive drug, the company said.

PARSIPPANY, N.J. — A federal court ruling has allowed Actavis to relaunch a generic contraceptive drug, the company said.

March 20, 2013

The Food and Drug Administration has approved and launched two generic contraceptives made by Sandoz, the drug maker said.

PRINCETON, N.J. — The Food and Drug Administration has approved and launched two generic contraceptives made by Sandoz, the drug maker said.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of Estarylla (norgestimate and ethinyl estradiol tablets) and Tri-Estarylla (norgestimate and ethinyl estradiol tablets), generic versions of Johnson & Johnson's Ortho Cyclen and Ortho Tri-Cyclen, respectively. Sandoz said the launches brought the total number of oral contraceptives it has launched since the beginning of 2011 to six.

January 22, 2013

The Food and Drug Administration has approved a generic contraceptive made by Lupin Pharmaceuticals, the drug maker said Tuesday.

BALTIMORE — The Food and Drug Administration has approved a generic contraceptive made by Lupin Pharmaceuticals, the drug maker said Tuesday.

Lupin announced the approval of levonorgestrel and ethinyl estradiol tablets in the 0.1 mg/0.02 mg strength, a generic version of Watson Labs' Lutera.

Lutera had sales of about $103.6 million during the 12-month period that ended in September 2012, according to IMS Health.

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.

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.

March 6, 2012

The Food and Drug Administration has approved a new formulation of a drug for postmenopausal women.

WAYNE, N.J. — The Food and Drug Administration has approved a new formulation of a drug for postmenopausal women.

Bayer HealthCare Pharmaceuticals said the FDA approved a lower-dose formulation of Angeliq (drospirenone and estradiol) tablets, used to treat moderate to severe vasomotor symptoms due to menopause in women who have a uterus. The new formulation contains 0.25-mg drospirenone and 0.5-mg estradiol, while the previously approved formulation contained 0.5-mg drospirenone and 1-mg estradiol.

March 2, 2012

Watson has launched an authorized generic drug for treating postmenopausal women, the company said Friday.

PARSIPPANY, N.J. — Watson has launched an authorized generic drug for treating postmenopausal women, the company said Friday.

Watson announced the launch of progesterone capsules in the 100-mg and 200-mg strengths, an authorized generic version of Abbott Labs' Prometrium, under an agreement with Abbott. Abbott will manufacture the drug and supply it to Watson, which will market and distribute it and share profits. Other terms were not disclosed, the companies said.

February 27, 2012

The Food and Drug Administration turned down an application for a topical reproductive drug made by Watson Pharmaceuticals and Columbia Labs, the two companies said Monday.

PARSIPPANY, N.J. — The Food and Drug Administration turned down an application for a topical reproductive drug made by Watson Pharmaceuticals and Columbia Labs, the two companies said Monday.

January 23, 2012

A panel of experts at the Food and Drug Administration has declined to recommend approval for a topical drug for preventing premature birth in pregnant women, the drug's manufacturers said.

PARSIPPANY, N.J. — A panel of experts at the Food and Drug Administration has declined to recommend approval for a topical drug for preventing premature birth in pregnant women, the drug's manufacturers said.

Columbia Labs and Watson Pharmaceuticals announced that the FDA's Reproductive Health Drugs Advisory Committee did not recommend approval for progesterone vaginal gel in the 8% strength. The drug is designed to reduce the risk of preterm birth in women with short uterine cervical length in the middle trimester of pregnancy.

October 11, 2011

Indian generic drug maker Lupin has launched an authorized generic version of a birth control pill made by Warner Chilcott, according to published reports.

NEW YORK — Indian generic drug maker Lupin has launched an authorized generic version of a birth control pill made by Warner Chilcott, according to published reports.

Dow Jones reported that Lupin launched an authorized generic of Femcon (norethindrone and ethinyl estradiol tablets, ferrous fumarate tablets).

An authorized generic is a branded drug sold under its generic name at a reduced price, usually through a third-party company.

 

July 28, 2011

Generic drug maker Watson Pharmaceuticals has launched a generic version of a contraceptive made by Duramed Pharmaceuticals, Watson said Thursday.

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals has launched a generic version of a contraceptive made by Duramed Pharmaceuticals, Watson said Thursday.

Watson announced the launch of Amethia (levonorgestrel and ethinyl estradiol [0.15 mg/0.03 mg] and ethinyl estradiol [0.01 mg]) after the U.S. Court of Appeals for the Federal Circuit denied Duramed’s request for a temporary injunction; a patent infringement lawsuit that Duramed filed against Watson remains pending.

June 27, 2011

The Food and Drug Administration has accepted a regulatory approval application for a drug designed to prevent premature birth in pregnant women.

LIVINGSTON, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a drug designed to prevent premature birth in pregnant women.

Columbia Labs and Watson Pharmaceuticals announced Monday that the FDA would review their application for Prochieve (progesterone gel) for the reduction of risk of preterm birth in women with short uterine cervical length in the third trimester of pregnancy.

June 1, 2011

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.

SILVER SPRING, Md. — 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.

April 27, 2011

A drug designed to reduce the risk of premature birth among pregnant women has been submitted to the Food and Drug Administration for approval.

LIVINGSTON and PARSIPPANY, N.J. — A drug designed to reduce the risk of premature birth among pregnant women has been submitted to the Food and Drug Administration for approval.

April 11, 2011

The Food and Drug Administration has approved an oral contraceptive made by Sandoz, the company said Friday.

PRINCETON, N.J. — The Food and Drug Administration has approved an oral contraceptive made by Sandoz, the company said Friday.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of Altavera (levonorgestrel and ethinyl estradiol) tablets, a generic version of Duramed’s Nordette.

Branded and generic versions of Nordette had sales of about $57.4 million during the 12-month period ended in February, according to IMS Health.

February 11, 2011

The Food and Drug Administration has approved a drug for preventing preterm births.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for preventing preterm births.

The agency announced Friday the approval of Baxter Pharmaceutical Solutions’ Makena (hydroxyprogesterone caproate) injection, for reducing the risk of preterm delivery before 37 weeks of pregnancy in pregnant women with a history of at least one spontaneous preterm birth.

November 29, 2010

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

CHAPEL HILL, N.C. — WomenCare Global has acquired two oral contraceptive brands from ICON, WomenCare said Monday.

The company acquired Roselle (levonorgestrel and ethinylestradiol) and Optinor (levonorgestrel). ICON developed both drugs under a partnership with an unnamed generic drug manufacturer.

“This partnership with WomenCare Global is a significant step forward in expanding access to quality-assured generic hormonal contraceptives at competitive prices,” ICON general manager David Smith said in a statement.

November 10, 2010

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