M2 PHARMA-September 22, 2017-Perrigo awarded US FDA for generic
Exalgo 32mg extended release analgesic tablets
The Food and Drug Administration stated that the company's products are therapeutically equivalent to Mallinckrodt's
Exalgo (hydromorphone HCI extended-release tablets) 8mg, 12mg and 16mg.
Extended-Release and Long-Acting Opioid Analgesics Requiring a Risk Evaluation and Mitigation Strategy Buprenorphine (Butrans) Fentanyl transdermal system (Duragesic) Hydromorphone hydrochloride (
Exalgo) Methadone hydrochloride (Dolophine) Morphine sulfate (Avinza, MS Contin, Kadian) Morphine sulfate and naltrexone hydrochloride (Embeda) Oxycodone hydrochloride controlled-release (OxyContin) Oxymorphone hydrochloride (Opana ER) Oxymorphone hydrochloride Extended-Release (Opana ER) Tapentadol (Nucynta ER) Note.
Boca Raton, FL, June 09, 2013 --(PR.com)-- Hydromorphone (Dilaudid,
Exalgo) is a potent synthetic opioid for relieving moderate to severe pain.
Interestingly, within the
Exalgo USPI record, the term 'limitations of use' appears exclusively in the Black Box, as 'warning: potential for abuse, importance of proper patient selection and limitations of use'.
Oramorph, oxycodone (OxyContin), hydromorphone (
Exalgo), transdermal fentanyl (Duragesic), buprenorphine (Butrans), and oxymorphone (Opana ER).
Approved in 2010,
Exalgo is an extended-release formulation of hydromorphone indicated for once-daily administration for the management of moderate to severe pain in opioid-tolerant patients who require continuous, around-the-clock opioid analgesia for an extended period.
Brand name Controlled-release contents Avinza Oral morphine Duragesic Transdermal fentanyl Embeda Oral morphine and naltrexone
Exalgo Oral hydromorphone Kadian Oral morphine Morphine sulfate contin Oral morphine Opana extended release Oral oxymorphone Oramorph sustained release Oral morphine Ultram extended release Oral tramadol Brand name Frequency taken/changed Avinza One a day Duragesic Every three days [topical] Embeda One or two a day
Exalgo One a day Kadian One or two a day Morphine sulfate contin Two or three a day Opana extended release Two a day Oramorph sustained release Two or three a day Ultram extended release One a day Table 2.
(Cambridge MA) won approval for its extended-release pain drug
Exalgo.
Exalgo is intended to treat moderate to severe pain in patients who require treatment with opioid painkillers for an extended period of time.
Its lead drug candidate is
EXALGO (hydromorphone HCl) Extended-Release Tablets.