Back to all Thought Leadership

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



Related Articles

FDA NDA

September 11, 2015

FDA Releases Draft Guidance for Industry on Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies

The FDA’s Office of Clinical Pharmacology within the Office of Translational Sciences released a new draft guidance document that, for the first time, clearly addresses the FDA’s recommendations and...

Read More
FDA North America

September 11, 2015

FDA Publishes Responses to Good Clinical Practice Inquiries

FDA Publishes Responses to Good Clinical Practice Inquiries: FDA oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and FDA’s regulations....

Read More
Compliance Life Science Consulting

September 11, 2015

FDA's Top 483 Observations for 2017: A Reflection of Industry's Compliance

At the beginning of each federal fiscal year, the US FDA posts the previous year’s Form 483 observation metrics issued by each product center. I find that reviewing these metrics provides a valuable...

Read More