NDMA

Individuals and Entities who Consumed and/or Paid for Valsartan or Valsartan‐Containing Drugs, a Class Action Lawsuit Could Affect Your Rights

Retrieved on: 
Monday, December 4, 2023
Nitrosamine, Migliaccio, Clerk, Plaintiff, Notice, LLP, Subclass, Class, District court, Active ingredient, NDEA, NDMA, Judgement, PO, Ritalin class-action lawsuits, Kanner, Court, TPP, Third party, Pharmaceutical industry, Defendant, Losartan, Lawsuit, Valsartan

The Court has not decided whether the Defendants did anything wrong or whether the Plaintiffs' claims have merit.

Key Points: 
  • The Court has not decided whether the Defendants did anything wrong or whether the Plaintiffs' claims have merit.
  • If you qualify as a member of a Class, you have the right to participate as a class member or to opt out.
  • You may visit the Case Website to register for case updates regarding the Lawsuit and any potential recovery or benefits to class members.
  • Opt-Out: All individuals and entities that satisfy a Class definition will be automatically included in the Class unless they choose to opt-out from the Class and Lawsuit entirely.

Press Release: Sanofi prevails in Zantac arbitration initiated by Boehringer Ingelheim

Retrieved on: 
Tuesday, June 20, 2023
GSK, International, Probability, Rx, Drinking water, European Medicines Agency, Philip Key (U.S. politician), Cancer, BI, Vegetable, NDMA, EMA, Boehringer Ingelheim, MDL, Ranitidine, Soil, OTC, FDA, Safety, International Chamber of Commerce, Commerce, Tobacco, Dietary supplement, Insurance, Pharmaceutical industry, Sanofi, Pfizer

Importantly, Sanofi remains confident that the defense of the underlying U.S. Zantac litigation is very strong.

Key Points: 
  • Importantly, Sanofi remains confident that the defense of the underlying U.S. Zantac litigation is very strong.
  • There is no reliable scientific evidence that Zantac causes the alleged injuries in the cases brought against GSK, Pfizer, BI, Sanofi, and others in the U.S. litigation.
  • In 2006, BI acquired the U.S. OTC rights for Zantac and in January 2017 Sanofi acquired those OTC rights.
  • Given the lack of scientific support for plaintiffs’ claims, Sanofi remains fully confident in its defenses to the litigation.

Judge Appoints Four Attorneys to Lead 77,000 Zantac Cancer Cases in Delaware

Retrieved on: 
Wednesday, May 17, 2023
GSK, GSK plc, Monsanto, Superior court, Cancer, N-Nitrosodimethylamine, NDMA, Liability, Wisner, Ranitidine, Case management, Heartburn, FDA, Roundup, Delaware Superior Court, Pharmaceutical industry, Tobacco

Judge Vivian L. Medinilla named Wisner and three others to the leadership position in a Case Management Order that applies to all Zantac (generic: ranitidine) cancer cases currently pending in the Superior Court of the State of Delaware.

Key Points: 
  • Judge Vivian L. Medinilla named Wisner and three others to the leadership position in a Case Management Order that applies to all Zantac (generic: ranitidine) cancer cases currently pending in the Superior Court of the State of Delaware.
  • "We look forward to presenting evidence at trial that Zantac causes cancer, and that the defendants have known about the risks for decades."
  • More than 77,000 people have Zantac lawsuits pending in Delaware state court alleging the widely used heartburn drug contains a known carcinogen called N-nitrosodimethylamine (NDMA).
  • The trial will be closely followed as the allegations in Mr. Goetz's case share many similarities to cases filed in Delaware.

PharmaTher Holdings Submits Fast Track Application to FDA for KETARX™ (Ketamine) for the Treatment of Parkinson’s Disease

Retrieved on: 
Tuesday, May 2, 2023
Diamond, Patent, Priority review, Communication, Motor disorder, CSE, Depression, Dyskinesia, New Drug Application, NDA, Accelerated approval (FDA), USD, NDMA, White Light Rock & Roll Review, Trial of the century, Movement, Pain, Hypertension, Plasma protein binding, Ketamine, Patient, Collection, Phase, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Levodopa-induced dyskinesia, LID, Food, Safety, Pharmaceutical industry

Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.

Key Points: 
  • Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.
  • NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
  • Summary results of the Phase I/II clinical study:
    Enrolled subjects with moderate to advanced Parkinson’s disease with a target infusion rate being 0.30 mg/kg/hr.
  • Parkinson’s disease is a debilitating disorder that affects an estimated 1 million people in the U.S. and 10 million people worldwide.

PharmaTher Holdings Announces Update of Type C Meeting with the FDA for KETARX™ (Ketamine) in Parkinson’s Disease

Retrieved on: 
Wednesday, March 29, 2023
Diamond, Patent, Motor disorder, CSE, Depression, Dyskinesia, Marketing, Fast Track, Type, USD, NDMA, Movement, Trial of the century, Pain, Hypertension, Ketamine, Patient, Risk, Phase, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Levodopa-induced dyskinesia, LID, Food, Safety, Pharmaceutical industry, Medical imaging, Risk management

The Company will provide updates to its clinical development initiatives as they arise.

Key Points: 
  • The Company will provide updates to its clinical development initiatives as they arise.
  • Summary results of the Phase I/II clinical study:
    Enrolled subjects with moderate to advanced Parkinson’s disease with a target infusion rate being 0.30 mg/kg/hr.
  • The maximum tolerated infusion rate ranged from 0.20-0.30 mg/kg/hr, which was dependent on either discomfort due to dissociation or hypertension.
  • Parkinson’s disease is a debilitating disorder that affects an estimated 1 million people in the U.S. and 10 million people worldwide.

Controlled-Release Formulations: Improving Stability and Efficiency, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Tuesday, March 21, 2023
MS, API, Excipient, Drug recall, NDMA, Extrusion

TORONTO, March 21, 2023 /PRNewswire-PRWeb/ -- Demand is driving the need for high-volume, high-speed tablet presses and this calls for improved manufacturing efficiency. Such presses subject materials to a higher strain rate, which creates challenges with tablet strength, weight uniformity and scale-up from lab to commercial manufacturing. Understanding the strain rate sensitivity of the API and excipients plays a critical role in tablet robustness, especially in the formulation of controlled-release dosage forms.

Key Points: 
  • In this free webinar, learn strategies to produce robust controlled-release tablets for the most challenging high-throughput commercial tableting conditions.
  • The featured speaker will discuss strategies to improve API and formulation stability by reducing the potential for nitrosamine formation.
  • Register to learn about the optimization of controlled-release formulations for high-speed, high-throughput manufacturing, with specific focus on improving efficiency and API stability.
  • Join Kapish Karan, MS, Global OSD R&D Leader, Pharmaceuticals, Ashland, for the live webinar on Wednesday, April 12, 2023, at 10am EDT (4pm CEST/EU-Central).

Slack Davis Sanger: Class-action lawsuits against generic Valsartan manufacturers moves forward

Retrieved on: 
Monday, February 13, 2023
Pharmacy, David Gal, NDEA, NDMA, Personal injury, Plasma protein binding, Failure, Hypertension, Carcinogen, FDA, MDL, Name, Blood pressure, Dietary supplement, Pharmaceutical industry, Losartan, Valsartan

Valsartan is a popular generic prescription medicine indicated to treat hypertension, and originally sold under the trade names of DIOVAN® and EXFORGE®.

Key Points: 
  • Valsartan is a popular generic prescription medicine indicated to treat hypertension, and originally sold under the trade names of DIOVAN® and EXFORGE®.
  • Since 1993, Slack Davis Sanger has been serving clients nationally and internationally with personal injury claims, wrongful death, and medical malpractice claims.
  • With a combined experience of more than 250 years, Slack Davis Sanger attorneys have extensive experience in litigation involving class action lawsuits and whistleblower cases.
  • For more information or to speak with John Davis, please contact Marketing Manager Stephanie Eitrheim at Slack Davis Sanger at 512-225-5322.

One lot of APO-Amitriptyline recalled due to a nitrosamine impurity

Retrieved on: 
Tuesday, February 7, 2023
Amitriptyline, Patient, NDMA, Risk, Pharmacy, Cancer, Health Canada, Tablet, Protriptyline, Medical device

OTTAWA, ON, Feb. 7, 2023 /CNW/ - Apotex Inc. is recalling one lot of APO-Amitriptyline 10 mg tablets due to the presence of N-nitrosodimethylamine (NDMA), a nitrosamine impurity, above the acceptable limit.

Key Points: 
  • OTTAWA, ON, Feb. 7, 2023 /CNW/ - Apotex Inc. is recalling one lot of APO-Amitriptyline 10 mg tablets due to the presence of N-nitrosodimethylamine (NDMA), a nitrosamine impurity, above the acceptable limit.
  • Patients should continue taking their amitriptyline drug, as the risks from not having adequate treatment outweigh possible effects of exposure to the levels of NDMA seen in the recalled product.
  • This means that long-term exposure to a level above what is considered safe may increase the risk of cancer.
  • Health Canada maintains a list of recalled amitriptyline drugs affected by this issue.

PharmaTher Holdings Submits FDA Meeting Package to Discuss Phase 3 Program and Fast Track Designation for KETARX™ (Ketamine) in Parkinson’s Disease

Retrieved on: 
Wednesday, February 1, 2023
Diamond, Ketamine, Food, Safety, Fast track (FDA), Fast Track, Trial of the century, Pain, Type, Motor disorder, LID, Accelerated approval (FDA), Depression, Patient, NDMA, Collection, CSE, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, Patent, Movement, Hypertension, Levodopa-induced dyskinesia, Dyskinesia, USD, Priority review, Pharmaceutical industry, Bookkeeping

In addition, the Company has requested guidance from the FDA to obtain Fast Track Designation for KETARX™.

Key Points: 
  • In addition, the Company has requested guidance from the FDA to obtain Fast Track Designation for KETARX™.
  • The goal date for the FDA in providing its written responses is March 20, 2023.
  • Summary results of the study:
    Enrolled subjects with moderate to advanced Parkinson’s disease with a target infusion rate being 0.30 mg/kg/hr.
  • Clinical programs conducted under Fast Track Designation may be eligible for Accelerated Approval and Priority Review of new drug applications if relevant criteria are met.

Baum Hedlund Aristei & Goldman is Now Wisner Baum

Retrieved on: 
Tuesday, January 10, 2023
Plaintiff, Transport, Accident, Retirement, Congress, HPV, MDL, Monsanto, County, Philosophy, DOJ, Culture, FDA, Ranitidine, PC, Hain Celestial Group, LLP, Bayer, The National Law Journal, Lawyer, N-Nitrosodimethylamine, NDMA, The American Lawyer, Goldman, Superior court, Dream, Daily, Tobacco, Pharmaceutical industry, Fine chemical, Gardasil, EU

Los Angeles, California, Jan. 10, 2023 (GLOBE NEWSWIRE) -- Baum Hedlund Aristei & Goldman, PC has changed its name to Wisner Baum, LLP.

Key Points: 
  • Los Angeles, California, Jan. 10, 2023 (GLOBE NEWSWIRE) -- Baum Hedlund Aristei & Goldman, PC has changed its name to Wisner Baum, LLP.
  • Vice president R. Brent Wisner , Baum Hedlund’s lead trial attorney, will serve as Wisner Baum’s new managing partner.
  • “I am honored to have the opportunity to lead this firm into its next chapter and eager to continue the legacy that Michael Baum, Paul Hedlund, Clark Aristei, and Ron Goldman built,” says Wisner.
  • 3:22-cv-00397) appointed Wisner Baum senior partner Bijan Esfandiari to serve as co-lead counsel for plaintiffs.