Bayer Extends Afrin Line With First OTC Oxymetazoline Spray In US For Children Under 6
Children’s Afrin regular and no-drip formulations reach US stores with consumers having choices between dozens of oxymetazoline nasal sprays available under an FDA OTC monograph. But products indicated for children was limited to one, Mucinex Childrens Stuffy Nose, and it’s for children 6 and up.
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India puts out rules for first set of over-the-counter drugs but provides no specifics on the pricing policy for such products or the wider switching pathway. Can the framework foster responsible self-medication and help reap value for patients in a market where the oversight of trade channels for sale of prescription-based drugs is lax?
Pharmacist groups’ representatives, in meeting with FDA officials, reiterate argument for greater role in access to OTCs through “additional conditions for nonprescription use.” Group not at meeting, American Society of Health-System Pharmacists, suggests “intermediate approach to nonprescription status.”
PhRMA captures tone of its comments saying “proposed rule might play an important role” in making more drugs available OTC. AAM also references gauntlet, saying proposed pathway “would, in theory, broaden the types of nonprescription drugs available to consumers.” CHPA discusses same concerns as well as additional questions for FDA.