Amneal Launches Etravirine Tablets – First Generic for Intelence
Amneal Pharmaceutical is now shipping Etravirine Tablets 100 mg and 200 mg following the June 14 approval of its Abbreviated New Drug Application from the FDA.
Amneal Pharmaceutical is now shipping Etravirine Tablets 100 mg and 200 mg following the June 14th approval of its Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA).
Etravirine is the first generic equivalent for Intelence® and indicated for treatment of HIV-1 infection in treatment-experienced patients 6 years of age and older. Severe, potentially life threatening and fatal skin reactions have been reported with use of Etravirine. Patients should be monitored for immune reconstitution syndrome and fat redistribution.
Amneal’s AB-rated Etravirine is packaged in 30-day unit-of-use bottles with child resistant caps: 100 mg as a 120-count size, and 200 mg as 60-count.
According to IQVIA®, U.S. annual Intelence® sales for the 12 months ended April 2021 were approximately $99.4 million.
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.
SOURCE: Amneal Pharmaceuticals, Inc.