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Amneal Closes Out Year With Flurry of New Generic Products.

BRIDGEWATER, N.J. -- Amneal Pharmaceuticals LLC has rolled out sevelamer carbonate tablets 800 mg, a generic version of Sanofi's Renvela tablets.

Amneal said the launch, announced in December, marked the 32nd product that it brought to market during 2017. The tablets come in 270-count bottles.

A phosphate binder, sevelamer helps to prevent low levels of calcium in the body (hypocalcemia) caused by elevated phosphorus. The drug is indicated to help control phosphorus levels in people with chronic kidney disease who are on dialysis.

U.S. sales of Renvela and its generic equivalents totaled $1.8 billion for the 12 months through October 2017, according to IQVIA market data reported by Amneal.

"Our approval and launch of sevelamer carbonate tablets is yet another example of Amneal's commitment to successfully provide complex pharmaceutical products to the U.S. market," stated Jim Luce, executive vice president of sales and marketing at Amneal. "Our pipeline continues to grow, with more than 132 ANDA's filed and another 140 in development."

Also in December, the company's Amneal Biosciences unit announced the release of triamcinolone acetonide injectable suspension 40 mg/ml, a steroid used to treat inflammation.

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

The Amneal triamcinolone acetonide injection will be sold in 1 ml singledose 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.

Triamcinolone injection is used for the treatment of 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 2017 market data from IQVIA.

Besides the Revela and Kenalog-40 generics, other recent launches from Amneal include busulfan injection 60 mg/10 ml (6 mg/1 ml), a generic version of Busulfex; progesterone capsules in 100 mg and 200 mg strengths, a generic of Prometrium; bumetanide tablets in 0.5 mg, 1 mg and 2 mg strengths, a generic of Bumex; ezetimibe and simvastatin tablets, a generic of Vytorin; and clonidine HC1 extended-release tablets in 0.1 mg strength, a generic of Kapvay.

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Title Annotation:Generic Drugs
Publication:Chain Drug Review
Date:Jan 15, 2018
Previous Article:U.S. Biosimilars Market Gets Boost in 2017.
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