Is topical preparation of Chlorpheniramine maleate (CPM) only (not in combination) approved by USFDA, EMA or any other regulatory body for allergic conjunctivitis?
If yes, then how CPM is marketed, OTC or scheduled drug.
This communication is consistent with 21 CFR 10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
According to Drugs@FDA there are no chlorpheniramine maleate products which are FDA approved in a topical or eye drop form for ocular allergy. Drugs@FDA can be accessed at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Best Regards,
HT
Drug Information Specialist
Division of Drug Information | Center for Drug Evaluation and Research
Food and Drug Administration
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This communication is consistent with 21 CFR 10.85(k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.