Ibuprofen (Unapproved) topical drug products

Ibuprofen (Unapproved) topical drug products
August 21, 2009

Audience: Consumers, pharmacists.

FDA informed consumers and healthcare professionals of its intent to
take action against eight companies that market unlawful
over-the-counter (OTC) topical drug products containing the pain
reliever ibuprofen. The products, which contain ibuprofen in
combination with a variety of other active ingredients and are
marketed for pain relief, are unapproved new drugs that require an
approved new drug application in order to be legally marketed.