Zdrowie i gospodarka · 29.05.2007
Timed-Release Drug Products Containing Guaifenesin; Enforcement Action Dates
The Food and Drug Administration (FDA) is announcing its intention to take enforcement action against unapproved drug products in timed-release dosage forms containing guaifenesin and persons who cause the manufacture or interstate shipment of such products. Hundreds of unapproved drug products in timed-release form containing guaifenesin, alone or in combination with other ingredients, are marketed to relieve the symptoms associated with cough, cold, and similar conditions. Such drug products require approved applications because they are not generally recognized as safe and effective for these uses. One firm has obtained approved applications to market timed-release products containing guaifenesin. Other firms who wish to market a drug product in timed-release form containing guaifenesin must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA).