InvaGen Pharmaceuticals, Inc., a wholly-owned subsidiary of the leading global pharmaceutical company Cipla Limited announced the receipt of final approval for its Abbreviated New Drug Application for Pregabalin Capsules, 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg from the United States Food and Drug Administration.
NEW YORK and MUMBAI, India, July 22, 2019 /PRNewswire/ -- InvaGen Pharmaceuticals, Inc. (“InvaGen”), a wholly-owned subsidiary of the leading global pharmaceutical company Cipla Limited (BSE: 500087; NSE: CIPLA EQ; hereafter referred to as “Cipla”) 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 $5.4 Billion for the 12-month period ending March 2019. The product is available for shipping immediately.
About Cipla:
Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets. Our strengths in the respiratory, anti-retroviral, urology, cardiology and CNS segments are well-known. Our 46 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT Mar'19), 3rd largest in the pharma private market in South Africa (IQVIA MAT Mar'19), and is among the most dispensed generic players in the US. For over eight decades, making a difference to patients has inspired every aspect of Cipla’s work. Our paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the movement. A responsible corporate citizen, Cipla’s humanitarian approach to healthcare in pursuit of its purpose of ‘Caring for Life’ and deep-rooted community links wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders. For more, please visit www.cipla.com, or click on Twitter, Facebook, LinkedIn.
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Company Codes: Bombay:500087, OTC-PINK:CPLFY, India:EQCIPLA
