FDA Grants Approval to Abbreviated New Drug Application for Leuprolide Acetate Injection in Advanced Prostate Cancer

The FDA has granted approval to an abbreviated new drug application for leuprolide acetate injection for patients with advanced prostate cancer, according to a press release from Amneal Pharmaceuticals.¹

This injection is indicated for palliative treatment in patients with advanced prostate cancer. The abbreviated application is used for the review and approval of generic drugs.² If the product is approved, manufacturing and marketing for it may begin. This will allow the drug to be produced as a safe, effective, and lower-cost alternative than the brand-name drug.

“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, senior vice president for Amneal Biosciences, said in the press release.

References

1. Amneal receives FDA approval for leuprolide acetate injection. News release. Amneal Pharmaceuticals. November 2, 2022. Accessed November 2, 2022. https://yhoo.it/3zChiuA
2. Abbreviated new drug application (ANDA). News release. FDA. Accessed November 2, 2022. https://bit.ly/3h9wkC1