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Opportunity for an Ear Drop NDA

September 11, 2015

The FDA’s announcement this summer that it would take enforcement action against several unapproved formulations of ear drops provides a great opportunity for a pharmaceutical company that would like to develop an NDA for this type of product.

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

Of course, FDA's action does not impact approved prescription products or legally marketed over-the-counter (OTC) products.

It is likely that the 505(b)(2) path could be followed for one of these compounds. Since these therapies have been available for decades it is possible that safety and efficacy could be demonstrated based on available relevant literature, thereby minimizing or eliminating the necessity of conducting clinical trials.

The Weinberg Group has assisted a number of clients in obtaining literature-based NDA approvals. The typical process is:

  • Development of Regulatory Strategy
  • Pre-IND Meeting
  • PREA Strategy
  • Pre-NDA Meeting
  • Development of NDA
  • NDA Submission
  • Approval Process/Dialogue with FDA
  • Approval

If you need assistance in developing an NDA for one of these ear drop formulations, or any other compound, please contact us.
Agency Alerts General Regulatory



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