Amneal Pharma Gets FDA Approval For Leuprolide Acetate Injection

(RTTNews) - Amneal Pharmaceuticals, Inc. (AMRX), an integrated essential medicines company, announced Wednesday that it has received Abbreviated New Drug Application or ANDA approval from the U.S. Food and Drug Administration for leuprolide acetate for injection.

Leuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer.

According to IQVIA, U.S. annual sales for this product for the 12 months ended September 2022 were $81 million.

In pre-market trade on the NYSE, Amneal Pharma shares were gaining around 2.2 percent to trade at $2.38.

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