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Amneal to release Kenalog-40 generic

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BRIDGEWATER, N.J. — Amneal Biosciences is set to roll out triamcinolone acetonide injectable suspension 40 mg/ml, a steriod used to treat inflammation.

Amneal said its triamcinolone acetonide product will be the only AP-rated generic equivalent injectable suspension available, with just the Kenalog-40 brand from Bristol-Myers Squibb currently on the market.

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“This important launch demonstrates the depth of our ability to successfully develop and manufacture complex products in our state-of-the-art manufacturing facilities,” stated Chirag Patel, co-CEO and co-chairman of Amneal Pharmaceuticals.

The Amneal triamcinolone acetonide injection will be sold in 1-ml single-dose vials as well as in 5-ml and 10-ml multiple-dose vials. The Kenalog-40 generic product will be available direct and via wholesalers and distributors.

“We are very pleased to launch the only generic injectable of triamcinolone, bringing this affordable medication to patients and health care providers,” Amneal Biosciences president Charles Lucarelli commented. “We will continue to focus on expanding our portfolio to provide quality generic injectables to our health care system.”

Triamcinolone injection is used to treat a range of inflammatory conditions, including severe allergic reactions, severe colitis, blood cell disorders, inflammatory eye disorders, lung disorders, acute gouty arthritis and rheumatic arthritis, among others.

Annual U.S. sales of Kenalog-40 injection were $146 million, according to October market data from IQVIA reported by Amneal.


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