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BRIDGEWATER, N.J. — Early next year, Amneal Pharmaceuticals LLC plans to launch an AB-rated generic version of Warner Chilcott’s discontinued Loestrin 24 Fe birth control pill.
Amneal said Thursday that its product (norethindrone acetate and ethinyl estradiol tablets 1 mg/20 mcg and ferrous fumarate tablets 75 mg) will be sold under the name Lomedia 24 Fe and rolled out to pharmacies in the first week of January.
Patients will be able to swallow the combination oral contraceptive whole as they did with Loestrin 24 Fe, according to Amneal, which reported that its product is an exclusive first-to-file generic equivalent for that brand.
Warner Chilcott, now part of Actavis, announced over the summer that it was discontinuing Loestrin 24 Fe with its introduction of a chewable version, Minastrin 24 Fe.
"We learned that many patients were concerned upon finding that their prescribed medication was discontinued by the brand manufacturer," stated Jim Luce, executive vice president of sales and marketing for Amneal. "We want those patients and their health care providers to know the generic equivalent is coming soon, that they will be able to continue using the therapy they’ve come to know and trust."
Loestrin 24 Fe was first approved by the Food and Drug Administration in February 2006. Its annual U.S. sales totaled $510.6 million before its discontinuation, with almost 9 million 28-day packs sold annually, supplying an estimated 800,000 patients, according to June 2013 IMS Health market data cited by Amneal.
