Perrigo Company has received final approval from the US 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 2017 were 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."