Search Results for Mylan

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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

Senate to Take on Pharmaceutical Prices Again: Real Reform or More of the Same? By Zachary Brennan - Published 12 June 2017

The Senate Health, Education, Labor & Pensions (HELP) committee is holding a hearing Tuesday on prescription drug costs and will look to address how the drug delivery system affects what patients pay.

Categories: News, US, FDA, Crisis management, Drugs, Government affairs

Tags: Senate HELP, Mylan, Valeant, Turing, drug prices

WHO: Prequalified Drugs Made at Mylan's Nashik Site do not Raise Quality Concerns By Michael Mezher - Published 02 June 2017

The World Health Organization Prequalification Team (WHO-PQT) said this week that it is no longer concerned about the quality of prequalified products made at Mylan Pharmaceuticals' Nashik, India site after the US Food and Drug Administration (FDA) warned the site over quality system issues in April.

Categories: News, India, FDA, WHO, Drugs

Tags: WHO Prequalification, Mylan, Nashik

Copaxone Generics: Who Will Win First Filer Exclusivity? By Zachary Brennan - Published 25 May 2017

Generic versions of Teva’s multi-billion-dollar per year multiple sclerosis drug Copaxone (glatiramer) are coming, but a closer look at which competitor might win the coveted 180-day exclusivity for its generic reveals an unusual and complex situation.

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

Tags: Copaxone, Teva, Mylan, Momenta, Synthon, Dr. Reddy's

FDA Warns Mylan Over Quality System Failures By Zachary Brennan - Published 11 April 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 3 April to Mylan Pharmaceuticals for its Nashik, India-based manufacturing site, which FDA said does not have a functioning quality system.

Categories: News, India, US, FDA, Drugs, Government affairs, Manufacturing

Tags: Mylan, ARVs, LMIC, HIV, Mylan India

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

Drug Companies Reveal Shortcomings in FDA Draft Guidance on Generic Topical Patches By Zachary Brennan - Published 18 August 2016

Mylan, Perrigo, AstraZeneca and Apotex are seeking more clarity and raising questions with the shortcomings of US Food and Drug Administration (FDA) draft guidance that aims to improve the way adhesion data is treated for abbreviated new drug application (ANDA) submissions of transdermal delivery systems and topical patches.

Categories: News, US, FDA, Clinical, Compliance, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Perrigo, Mylan, AstraZeneca, ANDAs for topical patches

Pharma Companies Warn of Regulatory ‘Dead Zone’ With FDA’s Interpretation of BPCIA By Zachary Brennan - Published 27 May 2016

Sanofi, Mylan, Novo Nordisk, and industry groups PhRMA and the Biosimilars Council are all calling on the US Food and Drug Administration (FDA) to amend its interpretation of the "deemed to be a license" provision of the Biologics Price Competition and Innovation Act (BPCIA) of 2010 as some are saying the current draft guidance could halt biosimilar development for a prolonged period.

Categories: News, US, DOJ, FDA, Biologics and biotechnology, Compliance, Product withdrawl and retirement

Tags: Sanofi, Mylan, PhRMA, GPhA, biosimilars, BPCIA

Agila Hit With Statement of GMP Non-Compliance From Polish Regulators By Zachary Brennan - Published 19 January 2016

Mylan subsidiary Agila Specialties has received a statement of good manufacturing practice (GMP) non-compliance from Poland’s Main Pharmaceutical Inspectorate at its Warsaw-based manufacturing site.

Categories: News, Europe, Compliance, Crisis management, Drugs, Manufacturing

Tags: Mylan, Agila, Main Pharmaceutical Inspectorate

FTC Takes Action Against Pharmaceutical 'Product Hopping' By Zachary Brennan - Published 02 October 2015

The Federal Trade Commission (FTC) on Thursday criticized the way brand-name drug manufacturers often tweak products' formulations shortly before a generic's entry to market, thereby delaying competition.

Categories: News, US, FTC, Advertising and Promotion, Generic drugs, Due Diligence, Ethics, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: product hopping, FTC, generic drug competition, Mylan, Warner Chilcott

Mylan Sues FDA, Seeking Earlier Approval for Generic Celebrex By Alexander Gaffney, RAC - Published 29 April 2014

Categories: US, FDA

Tags: Patent Reissue, Generic Drug, 180-Day Exclusivity, Mylan, Lawsuit, OGD, ANDA, Latest News, pharmaceutical

FDA Ordered to Approve Watson Laboratories' ANDA for Generic Actos Published 23 October 2012

Categories: FDA

Tags: Takeda, Actos, Approve, Diabetes, 180-Day Exclusivity, Mylan, ANDA, Watson, Teva, Latest News

Generic Boniva Approved, Marking Next Big Patent Expiry By Alexander Gaffney - Published 20 March 2012

Categories: FDA

Tags: Expiration, Ibandronate, Boniva, MedGuide, Apotex, Orchid Healthcare, Roche, Mylan, Generic, Latest News, Patent

FDA Rebuffs Attempt to Delay Generic Drugs By Scoring Pills By Alexander Gaffney - Published 10 February 2012

Categories: FDA, Manufacturing

Tags: Denied, 505(j), Pill, Acne, Doryx, Warner Chilcott, Scoring, Score, Mylan, Generic, ANDA, Citizen Petition, Latest News, Response

Hearing on Generic, Biosimilar User Fee Acts Scheduled for 9 February By Alexander Gaffney - Published 08 February 2012

Categories: FDA

Tags: Mylan, GPhA, Woodcock, BIPUF, Latest News, Drug Shortages, GDUFA