New Generic for Kenalog-40 Approved

Amneal launches only alternative to triamcinolone acetonide injectable.

Triamcinolone acetonide, a therapeutic corticosteroid used to treat inflammation, allergic reactions and other inflammatory disorders, is frequently administered to patients unable to take medicines orally. Amneal Biosciences announced that the FDA has approved its generic version of Kenalog-40, its triamcinolone acetonide Injectable Suspension, USP in 40 mg/mL dosage strength.

Ready to launch, Amneal Biosciences explained that the product is the only AP-rated triamcinolone acetonide generic equivalent available and will be marketed in single, 1 mL dose vials as well as in 5 and 10 mL vials. Chirag Patel, Co-CEO and co-Chairman for Amneal Pharmaceuticals commented: "This important launch demonstrates the depth of our ability to successfully develop and manufacture complex products in our state-of-the-art manufacturing facilities." Similarly enthusiastic about the prospects for the company’s newest sterile injectable, Amneal Biosciences’ President Charles Lucarelli said: "We are very pleased to … [be] bringing this affordable medication to patients and healthcare providers … [and] we will continue to focus on expanding our portfolio to provide quality generic injectables to our healthcare system."

According to October 2017 data from IQVIA, annual U.S. sales of Kenalog-40 reached some $146 million last year. Amneal Biosciences said their new product will be available direct and through wholesalers. Amneal Pharmaceuticals and its wholly-owned subsidiary Amneal Biosciences were founded in 2002. Located in Bridgewater New Jersey, the company employs 5,100 globally, focusing on developing generic versions of sterile injectables and anti-infectives to health care providers.


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