Advertisement The Medicines Company gets FDA approval for new formulation of Minocin for injection - Pharmaceutical Business review
Pharmaceutical Business review is using cookies

ContinueLearn More
Close

The Medicines Company gets FDA approval for new formulation of Minocin for injection

The Medicines Company (MDCO) has received approval from the US Food and Drug Administration (FDA) for its supplemental new drug application (sNDA) for a new formulation of Minocin (minocycline) for Injection.

Minocin for Injection is a tetracycline derivative approved in the US to treat 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.

MDCO Global Health Science, Infectious Disease Global Innovation Group senior vice-president and head Michael Dudley said: "We believe the new formulation of Minocin for Injection will offer clinicians an improved IV formulation that may allow for easier administration by using a lower fluid volume in patients with serious infections, including those caused by Acinetobacter spp.

"We are also pleased that FDA has recognized the potential value Minocin for Injection can bring to patients with difficult-to-treat infections due to serious pathogens by granting QIDP designation."

Under the Generating Antibiotic Incentives Now Act (GAIN Act), the FDA has also granted Qualified Infectious Disease Product (QIDP) designation for the new formulation of Minocin for Injection.

The QIDP designation would qualify Minocin for Injection for priority review and five years of marketing exclusivity upon an approval of the additional potential indications.