Mallinckrodt, the pharmaceuticals business of Covidien, has entered into an agreement with Xanodyne Pharmaceuticals to purchase Roxicodone (oxycodone hydrochloride tablets USP) in 5, 15 and 30 mg dosage strengths.
Roxicodone, currently marketed in the United States, is an immediate release formulation of oxycodone indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate. With this agreement, Mallinckrodt acquires all rights to the Roxicodone New Drug Application (NDA). No financial details were disclosed.
"We are excited about this agreement as it complements our existing portfolio of opioids and leverages our pain management expertise,” said Mark Trudeau, president, Pharmaceuticals. “More importantly, we are committed to safe and effective use of all of our products along with ensuring access for all patients in need of pain treatment.”
Mallinckrodt is the largest US supplier of opioid pain medications and among the top 10 generic pharmaceuticals manufacturers in the US, based on prescriptions. Its branded portfolio includes Exalgo (hydromorphone HCl) Extended-Release tablets (CII) and Pennsaid (diclofenac sodium topical solution) 1.5 per cent w/w. Mallinckrodt is also one of the world’s leading producers of bulk acetaminophen.
Covidien announced last December that the company planned to spin off Mallinckrodt into a stand-alone company, a process that is expected to be completed in mid-2013.
Roxicodone tablets are contraindicated in patients with known hypersensitivity to oxycodone, or in any situation where opioids are contraindicated. This includes patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia. Oxycodone hydrochloride tablets are contraindicated in any patient who has or is suspected of having paralytic ileus.
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