Errors Coughed Up For Dextromethorphan, Guaifenesin In US FDA Electronic Registrations
Three of seven businesses warned since February 2022 about noncompliance with FDA drug reporting requirements have been marketers of OTC cough/cold/congestion formulations made with dextromethorphan or guaifenesin.
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FDA drug user fee program chief tells OTC industry stakeholders accurate information in electronic Drug Registration and Listing System is key to setting annual facility registration user fee rates. CDER publishes warning letters to US retailer and a South Korean manufacturer noting noncompliance with eDRLS requirements.
Firms are returning to line extension activity for iconic brands such Alka-Seltzer, Robitussin, Triaminic and Vicks, some with OTC monograph ingredients added to provide new indications. Market researchers project category growth through 2014 and discuss factors affecting cough/cold product sales.
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