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Allergy & Immunology
PreHistin approval process to be conducted by OTC division of U.S. FDA
February 8th, 2006
Cobalis Corp. (CLSC), a pharmaceutical-development company specializing in antiallergy medications, announced that the company has been notified by the U.S. Food & Drug Administration (FDA) that the marketing approval process (investigational new drug application) for its antiallergy product, PreHistin, will now be conducted within the FDA by the Office of Nonprescription Products, the branch of the FDA which handles over-the-counter (OTC) drug products. The company sees this as a positive development since, as an FDA-approved OTC drug, PreHistin would not require a doctor's prescription, thus making consumer purchases easier, faster, and more convenient. Based on an...
Source: Immunotherapy Weekly (2006-02-08)
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