The Abbreviated New Drug Application (ANDA) for InvaGen Pharmaceuticals’ generic pregabalin capsules has received final approval from the FDA, according to the company.

InvaGen’s Pregabalin Capsules, 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg are therapeutically equivalent to Pfizer's pregabalin capsules (Lyrica). The product is immediately available for shipping.

According to Cipla, the parent company of InvaGen, 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
  • Management of neuropathic pain associated with spinal cord injury
IQVIA has estimated $5.4B in United States sales for Pfizer’s pregabalin capsules during the 12-month period ending March 2019, according to Cipla.


Reference

InvaGen (a Cipla Subsidiary) Receives Final Approval for Generic Version of Pfizer's Lyrica® (Pregabalin Capsules, 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg) [news release]. New York, NY and Mumbai, India; July 21, 2019: Cipla. https://prnmedia.prnewswire.com/news-releases/invagen-a-cipla-subsidiary-receives-final-approval-for-generic-version-of-pfizers-lyrica-pregabalin-capsules-25mg-50mg-75mg-100mg-150mg-200mg-225mg-300mg-300888411.html. Accessed July 22, 2019.