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.
(hydromorphone hydrochloride extended-release tablets 8 mg, 12 mg and 16 mg).
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'.
0 million milestone payment from its commercial partner Covidien following the FDA approval of Exalgo
on March 1, 2010.
Pre-Market NASDAQ Movers (VSEA, GMCR, ACLS, VCLK, AXTI, SGI, KTCC, MOTR, KNDI, FSLR, CENX, ZLCS)
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.
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.
Acthar gel is expected to complement Mallinckrodt's growth portfolio of leading specialty pharmaceutical brands, including Ofirmev, Exalgo
and Xartemis XR.
The company has recorded sales worth $167 million under specialty pharmaceuticals, reflecting a sound 25% boost from the sales figure of previous year, mostly because of robust presentation by its Exalgo
tablets as well as by its generic product portfolio.
M2 EQUITYBITES-August 28, 2012-Zalicus Inc gets FDA approval of 32mg dose strength of EXALGO
to help control chronic pain in opioid-tolerant patients(C)2012 M2 COMMUNICATIONS http://www.