Date: 2015-04-20
Type of information: Granting of a Market Authorisation in the US
Product name: new formulation of Minocin®
Compound: minocycline
Therapeutic area: Infectious diseases
Action mechanism: antibiotic/ protein-synthesis inhibitor/ tetracycline derivative
- In January 2018, The Medicines Company announced the closing of the sale of its infectious disease business unit to Melinta Therapeutics for consideration consisting of $215 million of guaranteed cash, approximately 3.3 million shares of Melinta common stock, tiered royalty payments of 5% to 25% on worldwide net sales of Vabomere™, Orbactiv® and
- Minocin® IV, and the assumption by Melinta of all royalty, milestone and other payment obligations relating to those products.
Company: The Medicines Company (USA - NJ)
Disease: infections due to susceptible strains of important designated gram-positive and gram-negative pathogens, including infections due to Acinetobacter species
Latest news:
- • On April 20, 2015, The Medicines Company announced that the 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. 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.
- The FDA granted QIDP designation for the following potential indications involving gram-negative pathogens:
- Treatment of hospital acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP).
- Treatment of persistent pulmonary infections in patients with cystic fibrosis caused by Burkholderia cepacia complex or Stenotrophomonas maltophilia.
- Treatment of pulmonary exacerbations in patients with cystic fibrosis caused by Burkholderia cepacia complex or Stenotrophomonas maltophilia.
- Treatment of pulmonary infections including pneumonia or lung abscess in patients with chronic granulomatous disease caused by Burkholderia cepacia complex.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2015-04-20
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes