FDA Approves Lyrica CR
The FDA recently approved an extended-release version of Pfizer’s Lyrica, Lyrica CR. Lyrica CR is approved for once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy and the management of post-herpetic neuralgia. The new CR version of Lyrica did not receive approval for the management of fibromyalgia. Lyrica currently has FDA-approval for all three indications and is dosed two to three times daily.
Pfizer’s new CR version of Lyrica is expected to enter the market in January 2018. This new drug release comes at a time when Pfizer is on the verge of losing the patent on Lyrica. Several manufacturers have tentative approvals to sell the generic formulation when Pfizer’s patent expires. Generic versions are expected to enter the market after Pfizer’s patent on Lyrica expires in December 2018.
Related Link: http://press.pfizer.com/