Pfizer : Receives Six Months Pediatric Exclusivity for LYRICA® pregabalin

Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for LYRICA®. This grant extends the period of U.S. market exclusivity for LYRICA by an additional six months, to June 30, 2019 (see also Pfizer Inc.).

LYRICA is currently approved in the U.S. for fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain and pain after shingles in adults. LYRICA is also approved as adjunctive therapy for the treatment of partial onset seizures in patients four years of age and older.

The pediatric exclusivity determination is based on data from the LYRICA Pediatric Epilepsy Program, which were submitted in response to the FDA’s Written Request to Pfizer to evaluate the use of LYRICA as adjunctive therapy for partial onset seizures in pediatric epilepsy patients. These were also required post-marketing studies.

https://www.marketscreener.com/PFIZER-23365019/news/Pfizer-Receives-Six-Months-Pediatric-Exclusivity-for-LYRICA-pregabalin-27718991/