FDA is taking another significant step in its unapproved drug enforcement initiative by ordering that hundreds of oral prescription (Rx) drugs used to treat coughs and colds be taken off the market.
In early March, FDA announced in the Federal Register its intention to take enforcement action against approximately 500 Rx cough/cold products “marketed without approved applications,” many of which are “inappropriately labeled for use in infants and young children.”
For a firm to market drug products, an approved new or abbreviated new drug application (NDA/ANDA) must be approved, or the product must comply with an FDA final monograph. The agency explained in announcing the new action that many of the targeted products contain active ingredients that “were introduced into the marketplace without prior review for effectiveness.” In addition, many of the drugs are manufactured in facilities that have not been inspected by FDA, and modifications to the manufacturing processes do not take place according to agency procedures.
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