Amneal Pharmaceuticals on Monday said it received abbreviated new drug application approvals from the U.S. Food and Drug Administration for some complex generic products.
The drug company said the approvals pertain to Medroxyprogesterone acetate injectable suspension, a generic version of Depo-Provera, and Dexmedetomidine Hydrochloride, a generic version of Precedex injection. Others include Nelarabine injection, Dapsone and Mometasone furoate nasal spray, generic versions of Arranon Injection, Aczone, and Nasonex, respectively.
The news came in tandem with Amneal's launch of an authorized generic of Xyrem oral solution CIII in the United States. The sodium oxybate oral solution is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness in patients seven years and older with narcolepsy.
"By adding these new medicines to our portfolio, Amneal is on track to launch more than 30 new generics products this year," said Chirag and Chintu Patel, co-chief executive officers.
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