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Aurobindo Receives FDA Approval for Oxycodone Hydrochloride Oral Solution USP, 5 mg/5 mL (1 mg/mL) and 100 mg/5 mL (20 mg/mL).

Published: February 07, 2020

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Oxycodone Hydrochloride Oral Solution USP, 5 mg/5 mL (1 mg/mL) and 100 mg/5 mL (20 mg/mL). Aurobindo’s Oxycodone Hydrochloride Oral Solution USP, 5 mg/5 mL (1 mg/mL) and 100 mg/5 mL (20 mg/mL) are an AB-rated generic equivalent to the reference listed drug, Oxycodone Hydrochloride Oral Solution USP, 5 mg/5 mL (1 mg/mL) and 100 mg/5 mL (20 mg/mL), of Genus Lifesciences, Inc.

Oxycodone Hydrochloride Oral Solution USP is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Oxycodone Hydrochloride Oral Solution USP has an estimated market size of US $33 Million for the twelve months ending December 2019 as per IQVIA.