As part of the Unapproved Drugs Initiatives, the Food and Drug Administration (FDA) announced it will take enforcement action against companies that manufacture and/or distribute unapproved prescription otic products labeled to relieve ear pain, infection, and inflammation.

The FDA has not evaluated the safety, efficacy, and quality of the unapproved prescription otic products that contain active ingredients such as benzocaine and hydrocortisone. Healthcare professionals may not realize the products are not approved since the product labels do not disclose that they do not have FDA approval. Use of unapproved drugs may place patients at greater risk because there they may be contaminated or manufactured incorrectly.

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The FDA informed companies that if they don’t stop manufacturing the unapproved prescription products, they may be subject to seizure, injunction and/or criminal proceedings. Unapproved prescription products containing the following ingredients are affected by this action:

  • Benzocaine
  • Benzocaine and antipyrine
  • Benzocaine, antipyrine, and zinc acetate
  • Benzocaine, chloroxylenol, and hydrocortisone
  • Chloroxylenol and pramoxine
  • Chloroxylenol, pramoxine, and hydrocortisone

Companies can submit a new drug application (NDA) or an abbreviated new drug application (ANDA) if they wish to market medications that are affected by this action.

The FDA’s action does not impact approved prescription products or legally marketed over-the-counter (OTC) products.

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