Vogelxo Receives AB-Rating to Testim
The FDA determined that Vogelxo (testosterone 1% gel), manufactured by Upsher-Smith therapeutically equivalent or what is also called is AB-rated, to Testim (testosterone 1% gel), manufactured by Auxilium. Both of these products are approved for treating men who have deficiencies or absences of natural testosterone.
Shortly after the approval of Vogelxo in June 2014, Upsher-Smith launched an authorized generic to its Vogelxo. Prasco is also marketing an authorized generic to Testim gel. Since these products are now deemed AB-rated, they are interchangeable at a pharmacy without contacting the prescriber.
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.