Over-The-Counter Sale of Differin Gel Approved
July 8, 2016 – The U.S. FDA announced the approval of Differin Gel 0.1% (adapalene), a once-daily topical gel for over-the-counter (OTC) treatment of acne in people 12 years of age and older. Differin Gel, manufactured by Galderma, was originally approved in 1996 for patients 12 years of age and older with acne vulgaris. Differin Gel 0.1% is the first retinoid acne treatment available OTC. Acne affects nearly 50 million people in the United States.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.