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MPR Weekly Dose Podcast

MPR Weekly Dose Podcast Episode 102

Contraindication added to Janssen COVID-19 vaccine; Pfizer announce final results for their COVID-19 oral antiviral; A new treatment for benign prostatic hyperplasia; REMS change for CAR T-cell therapy, and Rinvoq gains approval for active psoriatic arthritis. 
Drugs in the Pipeline

NDA Submitted for Novel Non-Metastatic CRPC Treatment

Apalutamide, an investigational, next generation oral androgen receptor inhibitor, was assessed for safety and efficacy in the Phase 3 pivotal trial, ARN-509-003 (SPARTAN), which the NDA is based on.
Drugs in the Pipeline

Generic Nilandron Now Available

ANI announced that the Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for nilutamide tablets, the generic version of Nilandron (Covis), indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer.
Generics News

Perrigo Approved for Generic Axiron Solution

Perrigo has received final approval from the Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Testosterone Topical Solution, the generic version of Eli Lilly's Axiron Topical Solution.