Pharma Focus Asia

Amneal Receives FDA Approval for Leuprolide Acetate Injection

Thursday, November 03, 2022

Amneal Pharmaceuticals, Inc., announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (“FDA”) for leuprolide acetate for injection.

Harsher Singh, SVP for Amneal Biosciences, stated, “We are making tremendous progress expanding our injectables business. This latest new product is another key therapeutic for the institutional market and another complex, high value launch by the team.”

Leuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer. For full prescribing information, see package insert located here.

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

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