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    2018 in Generic Drugs: Approvals Shine but Questions Remain on Competition

    The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) this week released its year in review, highlighting another banner year for approvals and new guidance documents. 2018 was the first year of GDUFA II, during which FDA implemented certain new provisions tied to the program and the FDA Reauthorization Act of 2017 (FDARA), including pre-ANDA meetings, reconsideration requests, one-time marketing status updates to the Orange Book and competitive gen...
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    Pfizer and Mylan Report EpiPen Label Defect Could Delay, Prevent Emergency Use

    The US Food and Drug Administration (FDA) recently issued a safety alert to inform that EpiPen manufacturer, Pfizer, has become aware that the label sticker on certain auto-injectors “may have been improperly applied, causing resistance when removing it from the carrier tube.”   The safety alert affects Mylan’s EpiPen 0.3 mg and EpiPen Jr 0.15 mg containing labeled expiries on both the devices and cartons between June 2018 and February 2020 and between October 2018 a...
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    Gottlieb: More Guidance on Complex Generics Coming

    The US Food and Drug Administration’s (FDA) difficulties in approving generic versions of complex products were front and center in Commissioner Scott Gottlieb’s comments at FDA’s Generic Drug Science Day on Tuesday. Complex generic drugs – often declared complex because of their unique formulations (such as ophthalmic suspensions like with Allergan’s Restasis (cyclosporine), gels or others like Janssen’s chemotherapy Doxil ), active ingredients (including peptides...
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    FDA Warns Pfizer Subsidiary Over Faulty EpiPen Components

    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. The warning letter comes less than six months after Meridian recalled 13 lots of EpiPens over concerns that a defective part could prevent the injectors from activating properly, and after a month-long inspection of Meridian's Brentwood, MO facility...
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    Mylan Settles With DOJ for $465M Over EpiPen Medicaid Rebates

    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.  The government contended that Mylan improperly avoided paying Medicaid programs higher rebates for branded drugs by misclassifying EpiPen as a generic drug, even though EpiPen had no FDA-approved the...
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    Human Factors Studies for Generic Combo Products: FDA Offers Draft Guidance

    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. The draft comes as the controversy over Mylan’s EpiPen has simmered down, though the only current gener...
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    HHS Inspector General to Examine Medicaid Drug Rebate Program in Wake of EpiPen Fiasco

    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. OIG’s review will examine the accuracy of Medicaid drug rebate classification data, the US Food and Drug Administration’s (FDA) approval status for drugs paid for by t...
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    Mylan CEO Defends EpiPen Price Increases

    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.” "When people realize what we have invested in ... this device has 15 critical components in it, I wouldn't undermine its importance," Bresch, who declined to attend a Senate committee hearing on the price increases earlier this week, told the Forbes Healthcare Summit,...
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    Senator Seeks More From Mylan on Intent to Repress Teva’s EpiPen Generic

    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. Background As part of an attempt to quell the furor over its more than 400% price increase for its life-saving EpiPen, Mylan announced in August that it would soon launch an authorized generic version of its autoinjector for half the price of the brand-n...
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    Senators Question Mylan CEO Over EpiPen Pricing, Generic Plans

    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. The letter comes just one day after the House Oversight and Government Committee launched an investigation into Mylan's "virtual monopoly over the epinephrine auto-injector market." In a separate letter to Bresch se...
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    Authorized Generics: Why Mylan Would Compete With Itself in the EpiPen Market

    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. The identical generic two-pack of EpiPens, expected to launch in several weeks , will have a list price of $300, which is half the list price of the brand product, but still significantly more than the price was prior...
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    Senators to FDA: Where are the Alternatives to Mylan’s EpiPen?

    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. The letter comes amid a frenzy of Congressional outrage over the more than 400% spike in the price of Mylan’s life-saving EpiPen for those suffering from severe allergies that hasn’...