image credit: Unsplash

FDA Cites Travel Restrictions in CRL

June 22, 2020

Via: PharmTech

Nabriva Therapeutics, a Dublin, Ireland-based biopharmaceutical company, announced on June 19, 2020 that it received a complete response letter (CRL) from FDA noting the agency was not able to conduct on-site inspections at a contract manufacturing facility used by Nabriva due to pandemic-related travel restrictions.

The letter was in response to the company’s resubmission of a new drug application (NDA) seeking marketing approval of CONTEPO (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis.

Read More on PharmTech