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news.Ohm Laboratories, a subsidiary of Ranbaxy Laboratories, has received approval from the Food and Drug Administration to manufacture and commercialize its antihistamine tablets, loratadine.
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The antihistamine previously made the switch from the prescription to the over-the-counter market. The Division of Bioequivalence has determined Ranbaxy’s loratadine orally disintegrating tablets, 10mg, to be bioequivalent to the branded drug, Claritin Reditabs, 10mg, of Schering Plough Healthcare Products. Loratadine is a long-acting antihistamine agent, which, in the orally disintegrating form, has annual sales of $58.7 million.
Loratadine is indicated for the temporary relief of runny nose, sneezing, itching of the nose or throat, itchy watery eyes due to hay fever or other respiratory allergies in adults and children six years of age and older.
Ohm Laboratories said the switch to over-the-counter would provide greater access to the product. The company expects loratadine to be available in June this year.