Content about norethindrone acetate

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.

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.

 

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.

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.

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.