Setback for long-acting granisetron
This article was originally published in Pharmaceutical Approvals Monthly
A.P. Pharma has received a "complete response" letter from FDA for its long-acting form of the chemotherapy-induced nausea and vomiting drug granisetron, a 5-HT3 antagonist, the firm announced March 19. The product, called APF530, is based on the company's proprietary Biochronomer drug delivery system. The letter cited concerns about the product's dosing administration system, which involves use of two syringes, deficiencies in contract manufacturing facilities, and concerns about sterilization practices. No new clinical studies will be required, but additional bioeqivalence and metabolism studies are needed. The firm has already submitted some of the data
You may also be interested in...
CRLs FDA submits in response to ANDAs increased most years since FY 2015, though FY 2020 total likely will be lower than two previous years. A 2019 CRL interrupted GSK's plans to market first mouth spray nicotine replacement therapy in US.
The US FDA appears to have concerns about the device used to administer the vaccine.
The US Medicare agency has released a quick-start guide for laboratory certification.