Medicines Co. Says FDA Okays New Formulation Of MINOCIN For Injection

(RTTNews) - Medicines Co. (MDCO) said that the U.S. Food and Drug Administration or FDA has approved a supplemental new drug application or 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.

MINOCIN for Injection is a tetracycline derivative approved in the U.S. The approved indications for MINOCIN for Injection includes the treatment of infections due to susceptible strains of several important designated gram-positive and gram-negative pathogens, including infections due to Acinetobacter species, which typically occur in hospitalized patients.