FDA Acts on Unapproved Ear Drop Products

FDA announced on July 1 its intention to take enforcement action against companies that manufacture or distribute certain unapproved prescription otic or ear drop products labeled to relieve ear pain, infection, and inflammation.

The unapproved prescription ear drops targeted contain active ingredients such as benzocaine and hydrocortisone, and have not been evaluated by the FDA. The labels on these products do not disclose that they lack FDA approval, and health care professionals may not be aware of their unapproved status. 

In a Federal Register notice, the agency informed the companies that they must stop manufacturing these unapproved prescription otic products or be subject to enforcement actions, including seizure, injunction and/or criminal proceedings. The action does not affect FDA-approved prescription otic products, or legally marketed otic products sold over-the-counter.

Unapproved prescription otic drug products containing benzocaine; benzocaine and antipyrine; benzocaine, antipyrine, and zinc acetate; benzocaine, chloroxylenol, and hydrocortisone; chloroxylenol and pramoxine; and chloroxylenol, pramoxine, and hydrocortisone are covered by the action.

Companies making and selling unapproved otic drug products covered by this action that are not currently listed with the FDA must stop manufacturing and shipping the products immediately. Companies that wish to market the drug products covered by this action can submit a new drug application (NDA) or an abbreviated new drug application (ANDA) for the FDA to consider approval of these products, FDA reports in a statement.

Source: US Food and Drug Administration