Opana ER Pulled from U.S. Market Last month, the U.S. Food and Drug Administration (FDA) asked Endo Pharmaceuticals to remove oxymorphone hydrochloride extended release (Opana ER) from the U.S. market due to public health consequences related to abuse. The agency has concerns that the risks presented by the treatment do not outweigh its benefits.1 On…
The Osteoarthritis Research Society International (OARSI) held the 2017 OARSI World Congress in Las Vegas, April 27–30. Below, we report on two of the sessions held. Retinoic Acid & Hand Osteoarthritis Retinoic acid is a vitamin A derivative and hormonal signaling molecule with a role in cartilage and skeletal development. Retinoic acid has complex function,…
NEW YORK (Reuters)—Generic drug makers are turning to mergers and acquisitions to shield themselves against a concerted effort by U.S. regulators to crack down on steep drug prices. Impax Laboratories Inc, Perrigo Company Plc and Alvogen Inc have been talking to advisers about strategic options for their generics businesses, ranging from acquisitions to increase scale…
The AMA House of Delegates (HOD) met in Chicago for its annual meeting June 9–14. More than 530 HOD members were present, with several hundred AMA and association staff and guests. As I am sure you have noted from past issues of ACR@Work, the ACR is in its five-year membership review. The ACR must be…
“I was hoping for good news, but now I am worried,” was the response of a 29-year-old patient when I suggested an oncology referral. He was four months into treatment of dermatomyositis and had experienced significant improvement of his muscle strength, CPK levels and interstitial pneumonitis, but a follow-up CT scan showed that his spleen…
(Reuters)—CVS Health Corp. has paid $5 million to resolve allegations that pharmacies it operates in California failed to keep and maintain accurate records of prescription drugs, the U.S. Justice Department said on Tuesday. The deal follows an investigation that began in 2012 after the U.S. Drug Enforcement Administration noticed an increased number of thefts and unexplained…
Endo Pharmaceuticals will work with the FDA to coordinate the organized removal of Opana ER from the U.S. market.
The FDA has asked the manufactures of Opana ER to remove the opioid from the U.S. market due to the public health risk of abuse…
Oxycodone Tablets Submitted to FDA Filings for oxycodone tablets (Oxaydo) in both 10 and 15 mg doses have been accepted by the U.S. Food and Drug Administration (FDA).1 The submission is based on a pharmacokinetic study demonstrating bioequivalence to the reference drug, oxycodone hydrochloride (Roxicodone) tablets at a 15 mg dose. The product is an…
(Reuters)—A synthetic version of a medicine traditionally extracted from chili plant relieved knee pain among osteoarthritis patients for up to six months, data showed, bringing Centrexion Therapeutics a step closer to developing a safe and effective analgesic. The drug, designed to be injected at the site of pain, is being developed by the privately-held company…