King Pharmaceuticals to resubmit Remoxy application to FDA
BRISTOL, Tenn. Drug maker King Pharmaceuticals hopes to get approval for a long-acting pain drug next year when it resubmits an approval application that the Food and Drug Administration rejected in December 2008.
The FDA rejected the application for the drug Remoxy (oxycodone) submitted last year by Pain Therapeutics, but King met with the agency earlier this month and emerged with a path to resubmit it, which it hopes to do in the middle of 2010.
King plans to submit six-month stability data with the application, though it doesn’t have to conduct new clinical trials, the company said. King assumed full responsibility for the development of the drug following the FDA’s rejection of Pain Therapeutics’ application.
CVS Caremark renews distribution agreements
SAN FRANCISCO McKesson has renewed its distribution agreement to supply CVS Caremark with branded and generic drugs, the company announced on Monday.
“CVS Caremark’s decision to renew its agreement with McKesson is reflective of the trusted relationship between our two companies and the value McKesson has delivered to CVS Caremark over the years,” stated Paul Julian, EVP, group president for McKesson. “McKesson’s comprehensive supply chain solutions help CVS Caremark ensure the highest levels of product availability and product integrity, empowering CVS Caremark to provide outstanding pharmaceutical care and further strengthen its competitive position.”
In related news, the retail giant also announced that it has renewed its distribution agreement with Cardinal Health. CVS Caremark said Cardinal Health will supply pharmaceuticals to its national network of retail pharmacies through mid-2013.
“We have a long-standing partnership with CVS Caremark, and we are proud to continue this important relationship,” said George Barrett, vice chairman of Cardinal Health and CEO of the Healthcare Supply Chain Services segment. “The footprint of the agreement is expected to be fundamentally the same as our existing relationship.”
Additional terms of the agreement were not disclosed.
FDA rejects application of pain-relief drug
PALATINE, Ill. The Food and Drug Administration has rejected an approval application for a pain-relief drug.
Acura Pharmaceuticals and King Pharmaceuticals announced that the FDA had issued a letter turning down their application for Acurox (oxycodone HC1, USP and niacin, USP), an immediate-release drug designed to relieve moderate to severe pain.
The companies said the letter expressed concerns about the potential abuse deterrent benefits of the drug. One of the drug’s ingredients, oxycodone, is a opiate-derived controlled substance popular with drug abusers.