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 InvaGen announces receipt of USFDA approval for pregabalin capsules
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InvaGen announces receipt of USFDA approval for pregabalin capsules

Agency News

Hyderabad, Jul 22 : InvaGen Pharmaceuticals, Inc. (InvaGen), a wholly-owned subsidiary of the leading global pharmaceutical company Cipla Limited on Monday announced the receipt of final approval from United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Pregabalin Capsules.

InvaGen’s Pregabalin Capsules was available in 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg is AB-rated generic therapeutic equivalent version of Pfizer’s Lyrica, the Global Pharmaceutical Company said in a release.

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 $5.4Billion for the 12- month period ending March 2019. The product is available for shipping immediately. Cipla,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.

Cipla is ranked third 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. (UNI)