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Drug Development
U.S. FDA grants orphan drug designation for pulmonary arterial hypertension drug
September 5th, 2004
Myogen, Inc. (MYOG), a biopharmaceutical company, announced that the U. S. Food and Drug Administration (FDA) has granted orphan drug designation to ambrisentan for the treatment of pulmonary arterial hypertension (PAH). Ambrisentan is being evaluated for PAH in two pivotal phase 3 trials, ARIES-1 and -2. The U.S. Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. Under the Orphan Drug Act, upon marketing authorization, the FDA does not accept or approve other applications to market the same medicinal product for the same therapeutic indication for a...
Source: Medical Letter on the CDC & FDA (2004-09-05)
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