מתוך medicontext.co.io
NEW YORK (Reuters Health) – Less than a month after receiving a unanimous recommendation for approval by a US Food and Drug Administration advisory panel, Actelion Ltd.'s pulmonary arterial hypertension drug Tracleer (bosentan) has received an approvable letter from the agency, the Swiss biotech firm said on Tuesday.
Tracleer, co-developed by South San Francisco, California-based Genentech Inc., is the first in a new class of drugs called endothelin receptor antagonists. It is also being tested for other indications, including congestive heart failure, and will be co-promoted by the two companies if it is ultimately approved.
The FDA's approvable letter indicates that Tracleer will receive final approval following finalization of the drug's label and the implementation of certain patient monitoring measures regarding elevated liver enzymes and possible birth defects associated with treatment, two issues raised by the advisory panel.
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