Allergies

Pharma company receives approval to manufacture and market Loratadine

Published in Medical Letter on the CDC and FDA, September 26th, 2004

Ranbaxy Laboratories Limited (Ranbaxy) announced that the company has received approval from the U.S. Food and Drug Administration to manufacture and market Loratadine Syrup (Loratadine Oral Solution, USP), 5 mg 5 mL that is available to patients as an OTC product.

The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent to that of the reference listed drug, Claritin Syrup, 5 mg5 mL, of Schering Corporation.

Loratadine is the generic equivalent of Scherings long acting tricyclic antihistamine agent Claritin, which has total market sales of $13.5 million (IRI MAT: July 2004).Loratadine...

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Source: Medical Letter on the CDC and FDA (2004-09-26)

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