Wyeth's Tygacil gets nod from EMEA's CHMP
US drug major Wyeth Pharmaceuticals has received a positive opinion from the European Medicine Agency's Committee for Medicinal Products for Human Use recommending approval of its first-in-class antibiotic Tygacil (tigecycline).
The firm welcomed the decision as the final step before formal clearance to market the agent in the 25 member states of the European Union, Iceland, Liechtenstein and Norway. The CHMP's recommendation will be forwarded to the European Commission for final approval, which is anticipated in the second quarter of 2006.
Tygacil, which has already been approved in six other countries: Brazil, Colombia, Mexico, Peru, Argentina and Ecuador, will be indicated for the treatment of complicated skin and soft-tissue infections and complicated intra-abdominal infections if cleared in Europe. The drug received clearance for use in the USA in June last year.
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