The Medicines Company (NASDAQ:MDCO ): FDA gives approval to new formulation of MINOCIN for Injection Print E-mail
By William Kent   
Monday, 20 April 2015 13:52

The Medicines Company (NASDAQ:MDCO)’s shares tumbled over 5% despite the company said that U.S. Food and Drug Administration has given approval to a supplemental new drug application (sNDA) for the fresh formulation of MINOCIN for Injection.

The FDA even gave approval to Qualified Infectious Disease Product (QIDP) designation for new formulation of MINOCIN for Injection under Generating Antibiotic Incentives Now Act.

This is the third one given to the firm in its infectious disease portfolio will also qualify MINOCIN for Injection for priority review as well as five years of exclusive marketing after approval of additional potential indications.

The US Centers for Disease Control and Prevention (CDC) considers the drug resistant Acinetobacter  to be a serious antimicrobial resistance threat.

CDC has given figures of number of deaths due to multi-drug resistant Acinetobacter to be much more than the Pseudomonas aeruginosa. There are figures that infection figures may be about 80,000 because of Acinetobacter species in a year in the country and about a million worldwide.

Michael Dudley, PharmD., Senior Vice President and Head of Global Health Science, Infectious Disease Global Innovation Group, The Medicines Company, opined that the new formulation of MINOCIN for Injection would provide clinicians a better IV formulation which may permit for faster administration by utilising fluid volume in patients having serious infections. He added that the company is glad that the FDA has recognised potential value can give patients difficult-to-treat infections.

Dr. Debra Goff, PharmD., FCCP Infectious Disease Specialist, The Ohio State University Wexner Medical Center, opined that Clinicians, regulators as well as public health authorities have recognized threat of multi-drug resistant bacteria to the healthcare system. He added that MINOCIN for injection is the best for identifying challenge of infections in the hospital.




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