us approve pfizer’s ‘norvasc’
TRANSCRIPT
22 MARKET NEWS
US approve Pfizer's 'Norvasc' The US health authorities have approved Pfizer's
once-daily calcium antagonist, amlodipine ('Norvasc ') for the treatment of hypertension and angina. The product is expected to be launched in the US in the last quarter of this year.
The labelling for 'Norvasc' appears to be cleanest of any drug in its class. The only warning and precaution statements are class-orientated. The labelling also notes that the drug has no significant pharmacokinetic effects with digoxin, phenytoin, warfarin, indomethacin and cimetidine.
Amlodipine is already available in many countries, the first being the UK in January 1990, as 'Istin' .
Pfizer are expected to submit a supplemental NDA for amlodipine to the FDA for the treatment of congestive heart failure mid next year.
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