Content about Estradiol

March 24, 2014

Upsher-Smith Laboratories on Monday announced that it has entered into a definitive agreement under which New Jersey-based Vertical Pharmaceuticals has acquired Upsher-Smith's rights to Divigel (estradiol gel) 0.1%, Nexa Plus Rx Prenatal Vitamin, and Provella, a probiotic dietary supplement.

MAPLE GROVE, Minn. — Upsher-Smith Laboratories on Monday announced that it has entered into a definitive agreement under which New Jersey-based Vertical Pharmaceuticals has acquired Upsher-Smith's rights to Divigel (estradiol gel) 0.1%, Nexa Plus Rx Prenatal Vitamin, and Provella, a probiotic dietary supplement. As part of the transaction, Upsher-Smith has transferred the new drug application for Divigel to Vertical Pharmaceuticals. 

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.

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.

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.

June 7, 2013

Actavis is hoping to become the first to market generic versions of a contraceptive and a sedative, the drug maker said.

PARSIPPANY, N.J. — Actavis is hoping to become the first to market generic versions of a contraceptive and a sedative, the drug maker said.

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 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.

January 30, 2013

A patch for treating menopause that the manufacturer calls the smallest is now available.

NEW YORK — A patch for treating menopause that the manufacturer calls the smallest is now available.

Noven Pharmaceuticals announced the availability of Minivelle (estradiol) transdermal system in pharmacies. The patch, which the Food and Drug Administration approved in October 2012, is designed for treating hot flashes and night sweats in women with menopause.

The patch has a surface area nearly the same as a dime at its lowest strength of 0.0375 mg-per-day and is 34% smaller than Noven's Vivelle-Dot patch, the company said.

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.

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.

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.

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.

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.

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.

January 19, 2012

Generic drug maker Watson Pharmaceuticals has launched its version of a contraceptive made by Bayer HealthCare Pharmaceuticals, Watson said.

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals has launched its version of a contraceptive made by Bayer HealthCare Pharmaceuticals, Watson said.

The company announced the launch of Vestura (drospirenone and ethinyl estradiol), a generic version of Bayer's Yaz.

Yaz and its generic versions had sales of about $510 million during the 12-month period ended in November, according to IMS.

November 21, 2011

Mylan will begin selling a generic drug for treating symptoms of menopause in two years, the company said Monday.

PITTSBURGH — Mylan will begin selling a generic drug for treating symptoms of menopause in two years, the company said Monday.

Following the settlement of a patent-litigation suit with Swiss drug maker Novartis over the patch Vivelle-Dot (estradiol transdermal system), Mylan said it had received a patent license to begin selling its version of the drug in December 2013.

November 11, 2011

An appeals court has thrown out an attempt by Teva Pharmaceutical Industries to stop Watson Pharmaceuticals from selling a generic contraceptive, Watson said.

PARSIPPANY, N.J. — An appeals court has thrown out an attempt by Teva Pharmaceutical Industries to stop Watson Pharmaceuticals from selling a generic contraceptive, Watson said.

The U.S. Court of Appeals for the Federal Circuit affirmed a lower court's June 16 decision to deny Duramed Pharmaceuticals' request for an injunction that would stop Watson from selling a generic version of Seasonique (levonorgestrel and ethinyl estradiol [0.15 mg/0.03 mg] and ethinyl estradiol [0.01 mg]). Duramed originally was a subsidiary of Barr Pharmaceuticals, which Teva acquired in 2008.

July 29, 2011

Teva Pharmaceuticals has launched an authorized generic version of a contraceptive made by Duramed Pharmaceuticals, Teva said.

JERUSALEM — Teva Pharmaceuticals has launched an authorized generic version of a contraceptive made by Duramed Pharmaceuticals, Teva said.

Teva announced the launch of Camrese, an authorized generic of Duramed’s Seasonique (levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets).

The launch of Teva’s authorized generic follows the launch of Watson Pharmaceuticals’ generic version of the drug, which it is marketing under the name Amethia.

July 26, 2011

Generic drug maker Lupin is seeking approval for a generic version of a contraceptive made by Warner Chilcott, according to published reports.

NEW YORK — Generic drug maker Lupin is seeking approval for a generic version of a contraceptive made by Warner Chilcott, according to published reports.

Reuters reported that Lupin had applied for approval of a generic version of Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets), an oral contraceptive.

June 8, 2011

The Food and Drug Administration has approved a generic oral contraceptive made by Sandoz, the company said Wednesday.

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

Sandoz, the generics arm of Swiss drug maker Novartis, announced the launch of Syeda (drospirenone and ethinyl estradiol) tablets in the 3-mg/0.03-mg strength.

The drug is a generic version of Bayer HealthCare Pharmaceuticals’ Yasmin. Yasmin and generic versions of the drug had sales of about $365 million during the 12-month period ended in April, according to IMS Health.

May 4, 2011

The Food and Drug Administration has approved a generic oral contraceptive made by Sandoz, the generics arm of Swiss drug maker Novartis said Wednesday.

PRINCETON, N.J. — The Food and Drug Administration has approved a generic oral contraceptive made by Sandoz, the generics arm of Swiss drug maker Novartis said Wednesday.

Sandoz announced the approval of Loryna (drospirenone 3 mg and ethinyl estradiol 0.02 mg) tablets, a generic version of Bayer HealthCare Pharmaceuticals’ Yaz.

May 2, 2011

Watson Pharmaceuticals has launched a low-dose chewable contraceptive, the company said Monday.

PARSIPPANY, N.J. — Watson Pharmaceuticals has launched a low-dose chewable contraceptive, the company said Monday.

Watson announced the U.S. commercial launch of Generess Fe (norethindrone and ethinyl estradiol chewable tablets, and ferrous fumarate chewable tablets) in the 0.8-mg/25-mcg strength.

March 2, 2011

A group of drug makers have sued Mylan over its attempt to gain Food and Drug Administration approval for a generic menopause drug, Mylan said Tuesday.

PITTSBURGH — A group of drug makers have sued Mylan over its attempt to gain Food and Drug Administration approval for a generic menopause drug, Mylan said Tuesday.

December 23, 2010

The Food and Drug Administration has approved the first and only low-dose oral contraceptive to combine 0.8-mg norethindrone and 0.025-mg ethinyl estradiol in a chewable form, with four 75-mg ferrous fumarate (iron) placebo tablets, Watson Pharmaceuticals has announced.

MORRISTOWN, N.J. — The Food and Drug Administration has approved the first and only low-dose oral contraceptive to combine 0.8-mg norethindrone and 0.025-mg ethinyl estradiol in a chewable form, with four 75-mg ferrous fumarate (iron) placebo tablets, Watson Pharmaceuticals has announced.

Watson's new oral contraceptive is positioned as a novel alternative to currently available birth control pills, and the dosing combination and 24-day active hormone regimen is intended to provide users with a low level of breakthrough bleeding and short, light, predictable periods.

October 21, 2010

The Food and Drug Administration has approved a new contraceptive from Warner Chilcott, the drug...

ARDEE, Ireland The Food and Drug Administration has approved a new contraceptive from Warner Chilcott, the drug maker said Friday.

 

The company said it plans to launch Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets) early next year. The company said the contraceptive contains the lowest dosage of estrogen — 10 micrograms — of any oral contraceptive currently available in the U.S. market.