Perrigo gets FDA final approval for generic version of Exalgo® 32mg extended release tablets
DUBLIN: Perrigo Company plc announced it has received final approval from the U.S. Food and Drug Administration (FDA) for its AB-rated Abbreviated New Drug Application referencing Exalgo® 32mg extended-release tablets (hydromorphone HCl). The company anticipates launching this product by the end of September 2017.
Exalgo® 32mg extended-release tablets (hydromorphone HCl) is an opioid agonist indicated for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. Annual market sales for the brand and generic equivalents of Exalgo® 32mg extended release tablets for the 12 months ended July 2017were approximately $35 million.
Perrigo Executive Vice President and President Rx Pharmaceuticals John Wesolowski stated, "This final approval exemplifies Perrigo's commitment to developing quality, high-value alternatives in important treatment categories. The Rx team continues to leverage our development capabilities to deliver Quality Affordable Healthcare Products® to customers, consumers and families around the world."
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