Amneal Launches Taysofy™ (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) – Generic for Taytulla®
August 5, 2021 -- Amneal Pharmaceuticals has launched Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules 1 mg/20 mcg following the July 20th approval of its Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA).
The Amneal product, marketed under the proprietary of TaysofyTM, is an AB-rated generic equivalent for the oral contraceptive brand Taytulla®. The drug carries a boxed warning regarding cigarette smoking and serious cardiovascular events and should not be used by women who are over 35 years of age and smoke.
According to IQVIA®, U.S. annual sales for Taytulla® and its generic equivalents in the 12 months ended June 2021 were approximately $124.4 million.
Taysofy™ is packaged in cartons containing 5 unit-of-use 28-day blister packs. Each blister pack contains 24 days of active therapy and 4 days of ferrous fumarate supplements.
Contact Amneal at (866) 525-7270 or Sales@amneal.com for more information.
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated pharmaceutical company focused on the development, manufacturing, and distribution of generic and specialty drug products. The Company has operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.
Amneal has an extensive portfolio of approximately 250 product families and is expanding its portfolio to include complex dosage forms, including biosimilars, in a broad range of therapeutic areas. The Company also markets a portfolio of branded pharmaceutical products through its Specialty segment focused principally on central nervous system and endocrine disorders.
The Company also owns 65% of AvKARE. AvKARE provides pharmaceuticals, medical and surgical products and services primarily to governmental agencies, primarily focused on serving the Department of Defense and the Department of Veterans Affairs. AvKARE is also a packager and wholesale distributor of pharmaceuticals and vitamins to its retail and institutional customers who are located throughout the United States focused primarily on offering 340b-qualified entities products to provide consistency in care and pricing. For more information, visit www.amneal.com.
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