33 results

• New Report Warns of Cancer-Causing Benzene in Generic Versions of Mucinex

  August 14, 2024

  Irvin Jackson

  A Bloomberg News special report warns that generic versions of the mucus-relief drug Mucinex uses an ingredient that puts consumers at increased risk of benzene exposure, which could result in increased cancer risks.

• Suboxone Settlement Results in Indivior Agreement To Pay Another $385M To Resolve Antitrust Lawsuit

  October 24, 2023

  Irvin Jackson

  Indivior has agreed to pay $385 million to resolve claims by states and wholesalers that it developed its Suboxone film strips, which have been linked to tooth damage, to prevent generic competition.

• Pentagon Asks Valisure, Not FDA, to Make Sure Drugs for Servicemembers are Safe

  June 13, 2023

  Irvin Jackson

  Bloomberg News reports that the Department of Defense is in talks with the independent drug testing lab Valisure to have it test generic drugs given to the military for safety and effectiveness.

• Nitrosamines Problems Are More Widespread in Drugs Than FDA Anticipated: Report

  November 1, 2022

  Irvin Jackson

  The FDA has been caught off-guard by the number of drugs being recalled for nitrosamine contamination and is likely to update a 2020 guidance to better address the problem according to a recent report.

• FDA Guidance Seeks to Speed Up Approval of Generic Drugs

  January 31, 2022

  Russell Maas

  The FDA has issued new guidance on how to speed up generic drug approval processes, amid existing concerns that the agency already approves many generic drugs too quickly and without a sufficiently rigorous review.

• Teva Mold Contamination Problems Result in Recall for 2.5M Drug Vials, Shut Down of California Plant

  October 5, 2021

  Irvin Jackson

  Teva has recently shut down a California manufacturing facility after recalling 2.5 million vials of unidentified drugs which may have had mold contamination.

• Generic Chantix Launched Following Recall of Name Brand Drug Due To Toxic Contaminant

  September 27, 2021

  Irvin Jackson

  The first generic version of Chantix has been announced just days after a complete recall of the brand name smoking cessation drug.

• FDA Seeks To Reassure Public On Generic Drug Oversight Following Valsartan Recalls

  May 22, 2019

  Irvin Jackson

  An FDA blog post says the agency is adequately protecting the country's generic supply chain following months of recalls and claims by a former inspector that the agency is dropping the ball.

• FDA No Longer Pursuing Rule Update to Require Generic Drug Makers To Warn Of Known Side Effects

  December 17, 2018

  Irvin Jackson

  The FDA is withdrawing a proposed rule that would have required generic drug manufacturers to update drug labels when dangerous side effects were discovered.

• Valsartan Problems Continue, With Identification of Second Cancer-Causing Impurity

  September 14, 2018

  Irvin Jackson

  Drug regulators warn that a second potentially cancer-causing impurity has been found in valsartan, requiring all recalled and unrecalled valsartan to be tested again.