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www.fdanews.com/articles/174786-fda-grants-dr-reddys-tentative-approval-for-generic-toviaz

FDA Grants Dr. Reddy’s Tentative Approval for Generic Toviaz

January 8, 2016

Indian drugmaker Dr. Reddy’s Laboratories scored a victory at the FDA, picking up tentative approval for its ANDA for fesoterodine fumarate, a generic version of Toviaz.

Toviaz — manufactured by Pfizer — is indicated for the treatment of overactive bladder symptoms, such as loss of bladder control or frequent need to urinate.

The news comes amid a rough patch for Dr. Reddy’s, which has been tangled up in GMP and data integrity issues with the FDA. Three of the drugmaker’s Indian plants received warning letters in November for repeat violations.