Sandoz Says FDA Approves Generics Of Two Oral Contraceptive Products

Sandoz Inc. March 19 announced that the Food and Drug Administration has approved Estarylla (norgestimate and ethinyl estradiol tablets) and Tri-Estarylla (norgestimate and ethinyl estradiol tablets), which are generic equivalents of the oral contraceptives Ortho Cyclen and Ortho Tri-Cyclen.

Estarylla and Tri-Estarylla are indicated for preventing pregnancy for those who use oral contraceptives for contraception, Sandoz said. Tri-Estarylla also is indicated for treating moderate acne in females at least 15 years old who also want an oral contraceptive for birth control.

Sandoz, a division of the Novartis group, said it has launched both products.

“We are pleased to add two ...