The Food and Drug Administration has accepted The Medicine Co.'s filing for Carbavance, which is used to treat complicated urinary tract infections.
Based on results from its Phase III TANGO 1 clinical trial in patients with complicated urinary tract infections, the company's new drug application filing will move forward with priority review.
“The exceptionally rapid development of Carbavance demonstrates the strong product discovery and development capabilities of The Medicines Co.’s infectious disease business and reflects our commitment to making innovative antimicrobial products available to patients with the most serious drug-resistant infections,” Dr. Clive Meanwell, CEO of The Medicines Co., said in a company press release.
“We believe that Carbavance could be a promising and highly-differentiated treatment option for these patients and we look forward to continuing our dialogue with the FDA during its review process,” he said.
FDA accepts The Medicines Co.'s filing for urinary tract infection drug
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