Generic to Androgel 1.62% Packets Approved
July 17, 2017 – The U.S. FDA has approved Perrigo’s A-rated generic to AbbVie’s Androgel® (testosterone gel) 1.62% packets, C-III. The drug is approved for the treatment of men who have deficiencies or absences of natural (endogenous) testosterone.
Perrigo has not yet announced launch plans for its Androgel 1.62% generic. U.S. sales of Androgel 1.62% packets were approximately $88 million for the 12 months ending May 2017. Generics for Androgel 1% have been available since January 2015.
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 U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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.