Content about norgestimate and ethinyl estradiol

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.

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.

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 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.