Sunday, 18 August 2019

Cipla gets final approval for generic version of Pfizer’s Lyrica

22 July 2019 | News

Cipla Limited announced the receipt of final approval for its Abbreviated New Drug Application (ANDA) for Pregabalin capsules

InvaGen Pharmaceuticals, Inc. (“InvaGen”), a wholly-owned subsidiary of the leading global pharmaceutical company Cipla Limited 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 Capsules, 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
  • Management of neuropathic pain associated with spinal cord injury 

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

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