First Generic Approved for Toviaz
October 5, 2017 – The U.S. FDA has approved a new generic, manufactured by Zydus Cadila, for Pfizer’s Toviaz® (fesoterodine fumarate) extended release tablets. This is the first generic to be approved for Toviaz, which is indicated to manage symptoms of overactive bladder that include urinary incontinence, urgency, and frequency. A muscarinic antagonist, fesoterodine fumarate has a recommended dosing of 4mg per day, which may be increased to 8mg per day if needed, provided the patient does not have severe renal impairment and is not taking strong CYP3A4 inhibitors, such as ketoconazole and clarithromycin.
Estimated sales of brand name Toviaz totaled $196 million in the twelve months ending on August 31, 2017. Plans for pricing and launch of Zydus Cadila’s generic product have not been announced.
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.