The Medicines Company today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for a new formulation of Minocin (minocycline) for injection.

The FDA has also granted Qualified Infectious Disease Product (QIDP) designation for the new formulation of MINOCIN for Injection under the Generating Antibiotic Incentives Now Act (GAIN Act). The designation, the third granted to a product in the Company’s infectious disease portfolio, would qualify Minocin for injection for priority review and five years of marketing exclusivity upon an approval of the additional potential indications.

Multi-drug resistant Acinetobacter is considered to be a serious antimicrobial resistance threat by the US Centers for Disease Control and Prevention (CDC). CDC estimates the number of deaths with onset in hospitalized patients due to multi-drug resistant Acinetobacter to be higher than those attributed to multi-drug resistant Pseudomonas aeruginosa. According to published estimates (Spellberg and Rex, Nature Reviews/Drug Discovery, 2013), there may be up to 80,000 infections due to Acinetobacter species annually in the US, and one million infections worldwide.

For more details, go to: http://ir.themedicinescompany.com/phoenix.zhtml?c=122204&p=irol-newsArticle&ID=2037570