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Perrigo awarded US FDA for generic Exalgo 32mg extended release analgesic tablets.

M2 PHARMA-September 22, 2017-Perrigo awarded US FDA for generic Exalgo 32mg extended release analgesic tablets

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Healthcare company Perrigo Company plc (NYSE:PRGO)(TASE:PRGO) reported on Thursday the receipt of final approval from the US Food and Drug Administration for its AB rated Abbreviated New Drug Application referencing Exalgo 32mg extended release analgesic tablets (hydromorphone HCl).

By the end of September 2017, the company plans to launch Exalgo 32mg extended release tablets (hydromorphone HCl) in the US market.

The company said 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.

For the 12 months ended July 2017, the annual market sales for the brand and generic equivalents of Exalgo 32mg extended release tablets were about USD35m.

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Publication:M2 Pharma
Date:Sep 22, 2017
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