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    Mylan Wins FDA Approval for First Advair Generic

    The US Food and Drug Administration (FDA) late Wednesday approved the first generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for the twice-daily treatment of asthma in patients aged four years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). Generating almost $80 billion in sales since its initial launch, competi...
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    The Battle Over Neulasta Biosimilars in the US: What's Coming in 2018

    2016 and 2017 were difficult years for companies trying to win US Food and Drug Administration (FDA) approval for biosimilars of Amgen's blockbuster for treating side effects from chemotherapy. Last June, Coherus Biosciences received a complete response letter (CRL) for its biosimilar of Neulasta (pegfilgrastim), with FDA requesting "a reanalysis of a subset of subject samples with a revised immunogenicity assay, and requests for certain additional manufacturing re...
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    FDA Denies 3rd Allergan Citizen Petition to Block Restasis Generics

    The US Food and Drug Administration (FDA) on Wednesday denied Allergan's third citizen petition attempting to block the agency from approving generic versions of the company's blockbuster Restasis (cyclosporine ophthalmic emulsion). "This is Allergan's third petition concerning the methods an ANDA [abbreviated new drug application] applicant might use to demonstrate that a proposed generic drug is bioequivalent to Restasis. As in its previous petitions and commen...
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    Updated: Copaxone Generics: Who Will Win First Filer Exclusivity?

    Generic versions of Teva's multi-billion-dollar per year multiple sclerosis drug Copaxone (glatiramer) have arrived, but a closer look at which competitor might win the coveted 180-day exclusivity reveals an unusual and complex situation. Back in January, a US District Court for the District of Delaware ruling invalidated all asserted claims  on Teva's patents on its 40 mg version of Copaxone, opening the door for generic competitors. Late Tuesday, Mylan  announce...
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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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    Senate to Take on Pharmaceutical Prices Again: Real Reform or More of the Same?

    The Senate Health, Education, Labor & Pensions (HELP) committee will hold a hearing Tuesday on prescription drug costs and look to address a problem many in America are grappling with: how the drug delivery system affects what patients pay. The hearing will likely address how pharmacy benefit managers (PBMs), insurers and others in the prescription drug ecosystem impact prices and what can be done to bring them down, though some are questioning whether anything subs...
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    WHO: Prequalified Drugs Made at Mylan's Nashik Site do not Raise Quality Concerns

    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. Background FDA's warning letter raised fears that a suspension of production at the site, which produces 21 WHO-prequalified antiretroviral drugs used to treat HIV/AIDs, ...
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    FDA Warns Mylan Over Quality System Failures

    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. "Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture," FDA said following a nine-day inspection in September 2016. The manufacturing site is ...
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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,...