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news.ANI Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Oxycodone Hydrochloride Oral Solution 5mg/5mL.
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Trailing twelve-month sales for the product are $30 million, according to IMS, with three current competitors. ANI expects to begin shipping to its customers shortly.
Arthur S. Przybyl, President and CEO of ANI Pharmaceuticals, stated, "This ANDA represents ANI’s first in the area of pain management and our first internally-developed product to receive approval. Pain management represents a strategic focus for the Company and ANI’s development pipeline includes several other products in that category."
ANI has forty-six generic drug products under development addressing a total annual market size of approximately $3.3 billion, based on data from IMS Health.
Oxycodone Hydrochloride Oral Solution 5mg/5mL is an opioid agonist indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.