Generic Pregabalin Capsules Receive FDA Approval

Article

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

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.

Related Videos
Image credit:  Gorodenkoff | stock.adobe.com
Sun Screen, Photosensitivity, Pharmacy | Image Credit: sosiukin - stock.adobe.com
Catalyst Trial, Diabetes, Hypertension | Image Credit: grinny - stock.adobe.com
Various healthy foods -- Image credit: New Africa | stock.adobe.com
LGBTQIA+ pride -- Image credit: lazyllama | stock.adobe.com
Modern pharmacy building facade with large window showcasing the interior, as seen from the street view, promoting a welcoming atmosphere for customers. Frontal view. Generative AI - Image credit: Karrrtinki | stock.adobe.com
Close up hands of helping hands elderly home care. Mother and daughter. Mental health and elderly care concept - Image credit:  ipopba | stock.adobe.com
© 2024 MJH Life Sciences

All rights reserved.