FDA clears Barr's generic Estrostep

Barr Pharmaceuticals says that its subsidiary, Barr Laboratories, has received approval from the US Food and Drug Administration for its Abbreviated New Drug Application to manufacture and market a generic version of Warner Chilcott 's Estrostep Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets) oral contraceptive product. The company will launch its product immediately under the trade name TriLegest Fe. Barr's generic oral contraceptive portfolio will now contain 25 products.

In April 2004, Warner Chilcott and Barr entered into an agreement to settle patent litigation under which the latter granted Barr a non-exclusive license to launch a generic version of Estrostep Fe in October 2007, six months prior to the last patent expiration on the drug.

As well as a method of contraception, Estrostep Fe is also indicated for the treatment of moderate acne vulgaris in females, 15 years of age, who have no known contraindications to oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications.