Novartis: A Swiss Drug Co. with a interest in Roche

ZURICH (AFX) - Novartis AG said blood pressure treatment Exforge has
received a tentative approval from the US Food and Drug Administration (FDA)
after meeting all required standards for safety, efficacy and manufacturing
quality.
The treatment is expected to be available in the US in late September, 2007,
pending the expiration of market exclusivity and patent protection for
amlodipine besylate.
Exforge combines in one tablet the two most commonly prescribed hypertension
medicines in their categories -- Diovan (valsartan) and Norvasc (amlodipine
besylate) -- the Basel-based drug maker said.
In an extensive clinical program involving over 5,000 patients, Exforge
helped up to nine out of 10 patients reach their treatment goal, Novartis said.
The EU's Committee for Medicinal Products for Human Use (CHMP) recommended
the drug for approval in November.
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