Drug major Cipla Monday said its subsidiary InvaGen Pharmaceuticals has received final approval from the US health regulator for Pregabalin Capsules, indicated for management of neuropathic pain associated with certain illnesses.
InvaGen has received approval from the the United States Food and Drug Administration (USFDA) for the drug in the strengths of 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg, Cipla said in a regulatory filing.
Cipla said the approved product is a generic therapeutic equivalent version of Pfizer's Lyrica.
Pregabalin capsules are indicated for management of neuropathic pain associated with diabetic peripheral neuropathy, management of postherpetic neuralgia, adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older, management of fibromyalgia and management of neuropathic pain associated with spinal cord injury.
Quoting IQVIA data, Cipla said Lyrica had an estimated market size of $5.4 billion for 12 months ending March 2019.
The product is available for shipping immediately, the company added.
Shares of Cipla were trading 0.18 per cent lower at Rs 535.90 apiece on the BSE.