Cubist get bulk drug facility approval

Published: 23-Feb-2005

Cubist Pharmaceuticals have received approval from the FDA for commercial production of the active ingredient in Cubicin (daptomycin for injection)at a second bulk drug facility, operated by ACS Dobfar S.p.A. (ACS) in Agnani, Italy.


Cubist Pharmaceuticals have received approval from the FDA for commercial production of the active ingredient in Cubicin (daptomycin for injection)at a second bulk drug facility, operated by ACS Dobfar S.p.A. (ACS) in Agnani, Italy.

Mike Bonney, Cubist president and ceo said: 'We are pleased to report this approval well within the Q1 timeframe that we promised. Approval of the ACS facility increases our capacity to manufacture daptomycin. This increases the security of supply, and it should help us to achieve our anticipated improvements in our gross margin.'

  

About Cubicin (daptomycin for injection)

Cubicin is currently the only once-daily bactericidal antibiotic approved in the US indicated for the treatment of complicated skin and skin structure infections caused by susceptible strains of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant strains), Streptococcus pyogenes, S. agalactiae, S. dysgalactiae subsp equisimilis and Enterococcus faecalis (vancomycin-susceptible strains only).

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