FDA approves Recarbrio for complicated urinary tract and complicated intra-abdominal infections.
Global Banking News-July 18, 2019-FDA approves Recarbrio for complicated urinary tract and complicated intra-abdominal infections
(C)2019 ENPublishing - http://www.enpublishing.co.uk
The US Food and Drug Administration (FDA) on Wednesday cleared the marketing of the antibacterial drug Recarbrio (imipenem, cilastatin and relebactam), for adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) under its Qualified Infectious Disease Product (QIDP) designation & Priority Review designations.
The agency reportedly granted the approval of Recarbrio to Merck & Co Inc (NYSE:MRK).
Recarbrio is a three-drug combination injection containing imipenem-cilastatin, an FDA-approved antibiotic, and relebactam, a new beta-lactamase inhibitor.
The determination of efficacy of Recarbrio was supported in part by the findings of the efficacy and safety of imipenem-cilastatin for the treatment of cUTI and cIAI. The safety of Recarbrio, administered via injection, was studied in two trials, one each for cUTI and cIAI. The cUTI trial included 298 adult patients with 99 treated with the proposed dose of Recarbrio. The cIAI trial included 347 patients with 117 treated with the proposed dose of Recarbrio.
((Distributed via M2 Communications - http://www.m2.com))
|Printer friendly Cite/link Email Feedback|
|Publication:||Global Banking News (GBN)|
|Date:||Jul 18, 2019|
|Previous Article:||Penske Automotive announces higher dividend of USD0.40 per share for Q2 2019.|
|Next Article:||Erchonia granted FDA approval of FX 635 for relief of chronic musculoskeletal pain.|