Health care company Pfizer Inc (NYSE:PFE) stated on Tuesday that the LYRICA has passed the US Food and Drug Administration's (FDA) paediatric exclusivity by an additional six months in the US.
The company said the US FDA has granted extension of the period of US market exclusivity for LYRICA by an additional six months to 30 June 2019.
In conjunction, the paediatric exclusivity determination is based on data from the company's LYRICA Paediatric Epilepsy Programme, which were submitted in response to the US FDA's Written Request to evaluate the use of LYRICA as adjunctive therapy for partial onset seizures in paediatric epilepsy patients.
According to the company, LYRICA is currently approved in the US for fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain and pain after shingles in adults as well as approved as adjunctive therapy for the treatment of partial onset seizures in patients four years of age and older.
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