Search Results for EpiPen

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FDA Warns Pfizer Subsidiary Over Faulty EpiPen Components By Michael Mezher - Published 07 September 2017

The US Food and Drug Administration (FDA) on Tuesday warned Pfizer subsidiary Meridian Medical Technologies for failing to adequately investigate faulty components used to make EpiPen and EpiPen Jr auto-injectors for Mylan.

Categories: News, US, FDA, Combination products, Drugs

Tags: Meridian Medical Technologies, Pfizer, Mylan, EpiPen, Warning Letter

Mylan Settles With DOJ for $465M Over EpiPen Medicaid Rebates By Zachary Brennan - Published 17 August 2017

Drugmaker Mylan announced on Thursday that it will pay $465 million to settle claims relating to the classification of EpiPen auto-injectors and EpiPen Jr. auto-injectors because of allegations of a misclassification of the product in the Medicaid Drug Rebate Program. 

Categories: News, US, DOJ, Drugs, Medical Devices

Tags: EpiPen, Mylan, Medicaid

Human Factors Studies for Generic Combo Products: FDA Offers Draft Guidance By Zachary Brennan - Published 13 January 2017

The US Food and Drug Administration (FDA) on Friday continued its flurry of draft guidance for generic drug companies (releasing its third in the last two days), this one for potential applicants planning to develop and submit an abbreviated new drug application (ANDA) to seek approval of a generic combination product that includes both a drug and a delivery device.

Categories: News, US, FDA, Clinical, Combination products, Compliance, Government affairs

Tags: Mylan, EpiPen, generic drug-device combination products, FDA draft guidance

HHS Inspector General to Examine Medicaid Drug Rebate Program in Wake of EpiPen Fiasco By Zachary Brennan - Published 12 December 2016

In light of concerns over the misclassification of Mylan’s EpiPen and subsequent overcharging of the federal government for the life-saving allergy drug, the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) late last week said it will review the Medicaid Drug Rebate Program.

Categories: News, US, FDA, Drugs, Government affairs, Reimbursement

Tags: CMS, EpiPen, Mylan, Andy Slavitt

Mylan CEO Defends EpiPen Price Increases By Zachary Brennan - Published 01 December 2016

Mylan CEO Heather Bresch on Thursday defended the more than 400% price increase for its life-saving EpiPen, saying the company has made the device “more ergonomic” and that patients “never see the needle.”

Categories: News, US, Business and Leadership, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: EpiPen, Mylan, Heather Bresch, generic drug price gouging

Senator Seeks More From Mylan on Intent to Repress Teva’s EpiPen Generic By Zachary Brennan - Published 28 September 2016

Sen. Patty Murray (D-WA) on Tuesday sent a letter to Mylan CEO Heather Bresch seeking more details, including e-mail communications, on the ways that Mylan attempted to keep Teva’s generic EpiPen from coming to market.

Categories: News, US, FDA, Crisis management, Drugs, Government affairs, Medical Devices, Regulatory strategy

Tags: Mylan, Teva, EpiPen, Patty Murray, citizen petition, pay-for-delay settlement

Senators Question Mylan CEO Over EpiPen Pricing, Generic Plans By Michael Mezher - Published 31 August 2016

A group of 20 Senate democrats on Tuesday sent a letter to Mylan CEO Heather Bresch, questioning her about her company's actions in response to criticism over price increases for its life-saving EpiPen, which rose in price more than 400% over the past decade.

Categories: News, US, FDA, Combination products

Tags: Mylan, EpiPen

Authorized Generics: Why Mylan Would Compete With Itself in the EpiPen Market By Zachary Brennan - Published 29 August 2016

As part of an attempt to quell the furor over its more than 400% price increase for its life-saving EpiPen, Mylan announced on Monday that it would soon launch an authorized generic version of its autoinjector for half the price of the brand-name product.

Categories: News, US, FDA, Generic drugs, Government affairs, Labeling, Regulatory intelligence, Regulatory strategy

Tags: Mylan, EpiPen, generic competition, authorized generics

Senators to FDA: Where are the Alternatives to Mylan’s EpiPen? By Zachary Brennan - Published 25 August 2016

Five senators from both sides of the aisle sent a letter to US Food and Drug Administration (FDA) Commissioner Robert Califf on Wednesday seeking more information on what the agency is doing to help authorize the use of EpiPen competitors that could bring down the cost of the autoinjector.

Categories: News, US, FDA, Combination products, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: EpiPen, Mylan, Robert Califf, Grassley, Klobuchar, Ron Johnson

Updated: Senate Judiciary Committee Members Call for Investigation Into Price Increases of Mylan’s EpiPen By Zachary Brennan - Published 22 August 2016

Sen. Amy Klobuchar (D-MN) on Saturday called on the Senate Judiciary Committee to hold a hearing to investigate the more than 400% price increase of Mylan’s EpiPen, a potentially life-saving auto-injector for those suffering from severe allergies.

Categories: News, US, FDA, FTC, Business and Leadership, Crisis management, Drugs, Government affairs, Medical Devices, Quality

Tags: EpiPen, Mylan, Andy Slavitt, Bernie Sanders