BRIDGEWATER, N.J.--(BUSINESS WIRE)--Amneal Pharmaceuticals LLC (“Amneal”) will launch its AB-rated generic for Loestrin® 24 Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets) 1 mg/20 mcg, 75 mg the first week of January 2014. Amneal’s exclusive First-to-File generic equivalent for this brand will be sold under the name Lomedia™ 24 Fe (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1mg/20mcg and Ferrous Fumarate Tablets*, 75mg). Patients will be able to swallow the pill whole just as they did with Loestrin® 24 Fe.
“We learned that many patients were concerned upon finding that their prescribed medication was discontinued by the brand manufacturer,” explains Jim Luce, Executive VP Sales & Marketing for Amneal. “We want those patients and their healthcare 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 FDA in February 2006. According to June 2013 IMS market data, annual U.S. sales were $510.6 million before its recent discontinuation with nearly 9 million 28-day packs sold annually, supplying an estimated 800,000** patients.
Amneal plans to sell Lomedia™ 24 Fe to wholesalers, distributors and direct to the trade. The company expects its new generic product to be in pharmacies the first week in January 2014.
Please click here to see the full prescribing information for Lomedia™ 24 Fe.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
About Amneal Pharmaceuticals LLC
Headquartered in Bridgewater, New Jersey, Amneal Pharmaceuticals LLC is a U.S.-based developer and manufacturer of high quality FDA-approved generic pharmaceuticals. The Company owns and operates manufacturing, R&D, packaging, sales and distribution facilities throughout the U.S. and abroad. Amneal prides itself on an unwavering commitment to quality, reliability and innovative approaches to maximizing value for all stakeholders. Amneal’s impressive growth has been spurred by extensive investment in R&D, intelligent product selection, aggressive geographic expansion, and a vertically integrated strategy. For more information, visit amneal.com.
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*Ferrous fumarate tablets are not USP for dissolution and assay.
**Patient
number derived from total sales divided by 12 for average number of
users over 12 months
