InvaGen receives final approval for Pregabalin Capsules

InvaGen Pharmaceuticals, a wholly-owned subsidiary of Cipla recently announced the receipt of final approval for its Abbreviated New Drug Application (ANDA) for Pregabalin Capsules, 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg from the United States Food and Drug Administration (US FDA).

InvaGen’s Pregabalin Capsule, 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg is AB-rated 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.

According to IQVIA (IMS Health), Lyrica had US sales of approximately $5.4 billion for the 12 month period ending March 2019. The product is available for shipping immediately.