Novartis to pay $30 mln to health plans, consumers over Exforge antitrust claims
Swiss drugmaker Novartis AG has agreed to pay $30 million to settle claims by health plans and consumers that it schemed to delay the U.S. launch of generic competition for its Exforge hypertension drug. In a motion filed in Manhattan federal court Wednesday, lawyers for the plaintiffs said the…#novartisag #exforge #manhattan #novartis #cvshealthcorp #alvinhellerstein #endointernationalplc #parpharmaceutical #par #plaintiffs (Source: Reuters: Health)
Source: Reuters: Health - February 23, 2023 Category: Consumer Health News Source Type: news

Novartis to Pay $245 Million to Settle Exforge Generics Lawsuit
(Source: Reuters: Health)
Source: Reuters: Health - December 29, 2022 Category: Consumer Health News Source Type: news

Novartis to pay $245 mln to end antitrust cases over Exforge drug generics
Novartis AG (NOVN.S) said on Wednesday it will pay $245 million to end antitrust litigation accusing the Swiss drugmaker of trying to delay the launch in the United States of generic versions of its Exforge hypertension drug. The settlements with so-called direct purchasers, indirect purchasers…#krogerco #exforge #southerndistrict #bradleyperrett #riteaidcorp #cvshealthcorp #jonathanstempel #manhattan #par #novartis (Source: Reuters: Health)
Source: Reuters: Health - December 29, 2022 Category: Consumer Health News Source Type: news

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceuti
Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 21, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity.
AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug producAurobindoPharma USA, Inc. is conducting a voluntary (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 21, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Exforge (Amlodipine and Valsartan) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - May 3, 2019 Category: Drugs & Pharmacology Source Type: news

amlodipine and valsartan (Exforge)
Title: amlodipine and valsartan (Exforge)Category: MedicationsCreated: 7/27/2010 12:00:00 AMLast Editorial Review: 3/19/2019 12:00:00 AM (Source: MedicineNet High Blood Pressure General)
Source: MedicineNet High Blood Pressure General - March 19, 2019 Category: Cardiology Source Type: news

AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity.
AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. This recall is an expansion of the recall initiated 12/31/18 The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) cl...
Source: Food and Drug Administration - March 1, 2019 Category: Food Science Source Type: news

Heart Drug Recall Expanded Again
(CNN) — The recall of popular heart drugs has expanded yet again. The US Food and Drug Administration said Thursday that Torrent Pharmaceuticals has added eight additional lots of losartan potassium tablets to its recall list. Losartan potassium is a drug used to control high blood pressure. It is also used to treat kidney disease in patients with diabetes. This recall includes 30-, 90- and 1,000-count bottles of 100-milligram tablets; 30-, 90- and 1,000-count bottles of 50-milligram tablets; and 90-count bottles of 25-milligram tablets. Torrent is recalling only these particular losartan potassium tablets. Tests fou...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - January 4, 2019 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News CNN Recall Valsartan Source Type: news

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient
– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochlorothiazide Tablets, USP (80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg strengths). (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 4, 2018 Category: Food Science Source Type: news

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient
Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. These products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in...
Source: Food and Drug Administration - November 21, 2018 Category: Food Science Source Type: news

UPDATED:ADDITIONAL LOTS ADDED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets
Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer ...
Source: Food and Drug Administration - August 22, 2018 Category: Food Science Source Type: news

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets
Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer ...
Source: Food and Drug Administration - August 22, 2018 Category: Food Science Source Type: news

ReCor Medical adds another $12m for trial of Paradise renal denervation device
ReCor Medical last week added a $12 million contribution from Otsuka Pharmaceutical (TYO:4578) to the $10 million it raised from the Japanese conglomerate last year for a clinical trial of its Paradise renal denervation device for treating hypertension, ReCor president & CEO Andrew Weiss told MassDevice.com this morning. In May 2016 Otsuka participated in a strategic investment of an unspecified amount; Weiss told us that that round and the $12 million debt financing added last week are earmarked for the Radiance-HTN efficacy study of the Paradise device, which is designed to use ultrasound waves rather than radi...
Source: Mass Device - August 16, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Funding Roundup Wall Street Beat Hypertension ReCor Medical Source Type: news

Exforge HCT (Amlodipine Valsartan Hydrochlorothiazide Tablets) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - October 31, 2016 Category: Drugs & Pharmacology Source Type: news