FDA Grants Approval to Abbreviated New Drug Application for Leuprolide Acetate Injection in Advanced Prostate Cancer
An abbreviated new drug application was granted approval by the FDA for leuprolide acetate injection for patients with 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
- Amneal receives FDA approval for leuprolide acetate injection. News release. Amneal Pharmaceuticals. November 2, 2022. Accessed November 2, 2022. https://yhoo.it/3zChiuA
- Abbreviated new drug application (ANDA). News release. FDA. Accessed November 2, 2022. https://bit.ly/3h9wkC1
Newsletter
Stay up to date on recent advances in the multidisciplinary approach to cancer.
Prolaris in Practice: Guiding ADT Benefits, Clinical Application, and Expert Insights From ACRO 2025
April 15th 2025Steven E. Finkelstein, MD, DABR, FACRO discuses how Prolaris distinguishes itself from other genomic biomarker platforms by providing uniquely actionable clinical information that quantifies the absolute benefit of androgen deprivation therapy when added to radiation therapy, offering clinicians a more precise tool for personalizing prostate cancer treatment strategies.
CCR Scores and Beyond: Precision Strategies for Treatment Intensification in Prostate Cancer
April 15th 2025Alvaro Martinez, MD discusses how emerging genomic risk stratification tools such as the clinical cell-cycle risk (CCR) score are transforming personalized prostate cancer treatment by enabling more nuanced assessments of metastasis risk and treatment intensification strategies beyond traditional NCCN risk groupings.
