Mylan Launches an Authorized Generic to EpiPen
December 16, 2016 - An authorized generic (AG) to EpiPen® (epinephrine injection) auto-injector is now available from Mylan Pharmaceuticals. Epi-Pen is a product indicated for the emergency treatment of severe allergic reactions, including anaphylaxis. An AG is the brand product in generic-looking packaging. It is available in 0.15 mg and 0.3 mg strengths and should be in retail pharmacies beginning next week. In 2015, U.S. annual sales for EpiPen were approximately $1.7 billion.
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 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.