FDA approves leuprolide acetate injection for palliative treatment of advanced prostatic cancer

The FDA has approved an abbreviated new drug application (ANDA) for leuprolide acetate for injection for the palliative treatment of advanced prostatic cancer, Amneal Pharmaceuticals, Inc., the developer of the treatment, reported in a news release.1,2

According to the FDA, an “ANDA contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.”3

Leuprolide acetate injection is a sterile, aqueous, clear, colorless solution that is administered through subcutaneous injection. According to the package insert for the product, the recommended dose is 1 mg (0.2 mL or 20 unit mark) administered to the patient through a single subcutaneous injection once daily.

The package insert also explains that a controlled study showed that leuprolide acetate (1 mg/day subcutaneous) had a comparable 2-year survival rate and objective response rate to DES (diethylstilbestrol; 3 mg/day).

The insert recommends monitoring response to leuprolide acetate injection by measuring serum levels of testosterone and PSA.

Of note, the majority of patients receiving leuprolide acetate injection will initially experience an increase in their serum testosterone level and may also experience worsening prostate cancer symptoms or the onset of additional symptoms of the disease. However, the insert explains that after the initial rise in testosterone, most patients experience a decline “thereafter to baseline levels or below by the end of the second week of treatment,” and further, “Castrate levels were reached within 2 to 4 weeks and once attained were maintained for as long as drug administration continued.”

Contraindications for leuprolide acetate injection include hypersensitivity to GnRH, GnRH agonist analogs, or any of the excipients in leuprolide acetate injection.

“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,” Harsher Singh, SVP for Amneal Biosciences, stated in the news release.


1. Amneal receives FDA approval for leuprolide acetate injection. News release. Amneal Pharmaceuticals, Inc. November 2, 2022. Accessed November 2, 2022.

2. Leuprolide acetate injection package insert. Amneal Pharmaceuticals, Inc. Accessed November 2, 2022. https://bit.ly/3sQ1LDU

3. Abbreviated New Drug Application (ANDA). U.S. Food & Drug Administration. Last updated January 14, 2022. Accessed November 2, 2022. https://bit.ly/2NXfN4L