Content about Hormonal contraception

April 23, 2013

The Food and Drug Administration has approved a new contraceptive drug made by Warner Chilcott, the drug maker said.

DUBLIN — The Food and Drug Administration has approved a new contraceptive drug made by Warner Chilcott, the drug maker said.

Warner Chilcott announced the approval of Minastrin 24 FE (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) for prevention of pregnancy.

The drug maker said an unnamed third-party company would manufacture the drug, but it did not expect to launch it this year.

 

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.

April 12, 2013

The Food and Drug Administration has approved a contraceptive therapy made by Lupin Pharmaceuticals, the Indian drug maker said Friday.

MUMBAI, India — The Food and Drug Administration has approved a contraceptive therapy made by Lupin Pharmaceuticals, the Indian drug maker said Friday.

Lupin announced the approval of Daysee (levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets) in the 0.15-mg/0.03-mg and 0.01-mg strengths.

The drug is a generic version of Teva's Seasonique. Various versions of the drug had sales of $161 million in 2012, according to IMS Health.

 

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. 

April 1, 2013

The Food and Drug Administration has approved a new contraceptive therapy made by Teva Pharmaceutical Industries, Teva said Monday.

JERUSALEM — The Food and Drug Administration has approved a new contraceptive therapy made by Teva Pharmaceutical Industries, Teva said Monday.

The drug maker announced the approval of Quartette (levonorgestrel, ethinyl estradiol and ethinyl estradiol) tablets. Teva said the drug represented the "next generation" of extended-regimen oral contraceptives and was designed to minimize breakthrough bleeding between scheduled periods.

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.

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. 

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.

January 10, 2013

The Food and Drug Administration has approved a new intrauterine device for preventing pregnancy made by Bayer HealthCare Pharmaceuticals, the drug maker said.

WAYNE, N.J. — The Food and Drug Administration has approved a new intrauterine device for preventing pregnancy made by Bayer HealthCare Pharmaceuticals, the drug maker said.

Bayer announced the approval of Skyla (levonorgestrel-releasing uterine system), which can prevent pregnancy for up to three years. The IUD contains 13.5 mg of levonorgestrel.

Nearly 50% of pregnancies in the United States are unintended, according to the National Center for Health Statistics.

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.

October 18, 2012

The Food and Drug Administration has approved a generic contraceptive made by Indian drug maker Lupin, the company said Thursday.

MUMBAI, India — The Food and Drug Administration has approved a generic contraceptive made by Indian drug maker Lupin, the company said Thursday.

Lupin announced the approval of Kurvelo (levonorgestrel and ethinyl estradiol) tablets in the 0.15 mg/0.03 mg strength.

The drug is a generic version of Teva's branded Nordette. Nordette had sales of about $59 million during the 12-month period ended in June, according to IMS Health.

August 13, 2012

The Food and Drug Administration is reviewing a regulatory application from Teva for a contraceptive drug, the company said Monday.

FRAZER, Pa. — The Food and Drug Administration is reviewing a regulatory application from Teva for a contraceptive drug, the company said Monday.

Teva Women's Health, part of Israeli drug maker Teva Pharmaceutical Industries, announced the FDA's acceptance of its application for Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol), which the company called the first ascending-dose, extended regimen oral contraceptive for preventing pregnancy.

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.

July 6, 2012

The Food and Drug Administration has accepted a new drug application for a low-dose, once-weekly contraceptive patch from Agile Therapeutics, the drug maker said.

PRINCETON, N.J. — The Food and Drug Administration has accepted a new drug application for a low-dose, once-weekly contraceptive patch from Agile Therapeutics, the drug maker said.

July 3, 2012

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

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

Lupin announced the approval of norgestimate and ethinyl estradiol tablets in the 0.18/0.025-mg, 0.215/0.025-mg and 0.25/0.025-mg strengths.

The drug is a generic version of Ortho Tri-Cyclen Lo, made by Johnson & Johnson subsidiary Janssen Pharmaceuticals. The branded version of the drug had sales of about $421 million during the 12-month period ended in March, according to IMS Health.

May 18, 2012

Generic drug maker Watson Pharmaceuticals is challenging the patent protection of a contraceptive drug made by Warner Chilcott, Watson said Friday.

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals is challenging the patent protection of a contraceptive drug made by Warner Chilcott, Watson said Friday.

The company announced that it had filed a regulatory application with the Food and Drug Administration for norethindrone acetate and ethinyl estradiol tablets in the 1-mg/0.01-mg strength and ethinyl estradiol and ferrous fumarate tablets in the 0.01-mg/75-mg strength. The treatment is a generic version of Warner Chilcott's Lo Loestrin Fe.

April 3, 2012

A drug maker and a charity organization are donating $3 million in contraceptives to uninsured women.

SANTA BARBARA, Calif. — A drug maker and a charity organization are donating $3 million in contraceptives to uninsured women.

Teva Pharmaceuticals and Direct Relief USA announced the donation of 5,000 units of the intrauterine contraceptive ParaGard to clinics and health centers serving low-income people, including the EXCELth Family Health Center in New Orleans.

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.

March 15, 2012

The Food and Drug Administration has approved a drug that the manufacturer called the first oral contraceptive that also treats heavy menstrual bleeding.

WAYNE, N.J. — The Food and Drug Administration has approved a drug that the manufacturer called the first oral contraceptive that also treats heavy menstrual bleeding.

Bayer HealthCare Pharmaceuticals announced Wednesday the approval of Natazia (estradiol valerate and estradiol valerate and dienogest) tablets for heavy menstrual bleeding not caused by any conditions of the uterus. The drug was originally approved as an oral contraceptive in May 2010.

February 28, 2012

The U.S. unit of Indian generic drug maker Glenmark is recalling a generic contraceptive drug, the company said.

NEW YORK — The U.S. unit of Indian generic drug maker Glenmark is recalling a generic contraceptive drug, the company said.

Glenmark Generics USA announced the recall of seven lots, imported from India, of norgestimate and ethinyl estradiol tablets in the 0.18-mg/0.035-mg, 0.215-mg/0.035-mg and 0.25-mg/0.035-mg strengths. The company said a packaging error resulted in blister packs being rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiration date visible only on the outer pouch.

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.

February 8, 2012

Subsidiaries of Watson Pharmaceuticals and Johnson & Johnson have settled a lawsuit filed by the latter when Watson attempted to market a generic version of one of its contraceptive drugs.

PARSIPPANY, N.J. — Subsidiaries of Watson Pharmaceuticals and Johnson & Johnson have settled a lawsuit filed by the latter when Watson attempted to market a generic version of one of its contraceptive drugs.

February 1, 2012

A possible pill mix-up has prompted Pfizer to recall more than two dozen lots of a prescription contraceptive drug, the drug maker said.

NEW YORK — A possible pill mix-up has prompted Pfizer to recall more than two dozen lots of a prescription contraceptive drug, the drug maker said.

Pfizer announced the voluntary nationwide recall of 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) tablets and 14 additional lots of the drug's generic version. Pfizer manufactured and packaged the drugs, while Akrimax Pharmaceuticals commercialized them, and they were sold under the Akrimax brand.