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Generics

  • FDA approves Perrigo’s hydrocodone bitartrate and homatropine methylbromide

    WASHINGTON — The U.S. Food and Drug Administration approved Perrigo’s hydrocodone bitartrate and homatropine methylbromide oral solution (syrup), 5 mg/1.5 mg per 5 mL.

    Hydrocodone bitartrate and homatropine methylbromide oral solution (syrup), 5 mg/1.5 mg per 5 mL is indicated for the symptomatic relief of cough in adults and children 6 years of age and older. Annual sales for the 12 months ending January 2017 were approximately $16 million, according to Perrigo. 

  • FDA sets record for generic drug approvals

    WASHINGTON — 2016 was a record-setting year for the U.S. Food and Drug Administration’s generic drug program, with its Center for Drug Evaluation and Research generating the highest number of approvals in its history — more than 800 generic drug approvals, including both full approvals and tentative approvals. 

  • Health care leaders gather in Washington

    WASHINGTON — Leaders across the health care continuum on Thursday gathered in Washington, D.C. to offer perspectives on efforts currently underway to move the healthcare system toward one that rewards innovation, delivers better quality and puts the patient at the center of the value equation. The meeting was convened by The Value Collaborative, an initiative of America’s biopharmaceutical companies, in partnership with Morning Consult.

  • Heritage Pharmaceuticals names Scott Delaney president
    EATONTOWN, N.J. — Specialty generic pharmaceutical company Heritage Pharmaceuticals announced Tuesday that it had named Scott Delaney to the position of president, effective March 1.
     
    Delaney, who has 24 years of generic and branded pharmaceutical experience, joins the company from Edenbridge Pharmaceuticals, where he was chief commercial officer. Prior to Edenbridge, he worked as Jubilant Cadista Pharmaceuticals’ president and CEO. He has also held various leadership positions at Teva, USA and H-E-B, as well as Eli Lilly.

  • FDA approves first heartworm generic for dogs
    SILVER SPRING, Md. — The Food and Drug Administration has approved the first generic of Diroban (melarsomine dihydrochloride), the agency announced recently. The drug is meant to treat heartworm disease in dogs. 
     
    The treatment is for dogs with stabilized class 1 (no symptoms), class 2 (mild to moderate respiratory symptoms) and class 3 (severe respiratory symptoms) heartworm disease. 
     

  • Lupin earns FDA approval for Hycodan generic

    WASHINGTON — The U.S. Food and Drug Administration approved Mumbai, India-based Lupin’s ANDA for hydrocodone bitartrate and homatrophine methylbromide oral solution (Syrup), 5 mg/1.5 mg per 5 ml. It is a generic of Endo Pharmaceuticals’s Hycodan Oral Solution, 5 mg/1.5 mg per 5 ml.

    Hycodan (hydrocodone bitartrate and homatropine methylbromide) is indicated for the symptomatic relief of cough in adults and children 6 years of age and older.

  • Mayne Pharma releases migraine generic

    GREENVILLE, N.C. — Mayne Pharma launched Butalbital acetaminophen (APAP) tablets, 50mg/300mg in the United States. Butalbital/APAP is indicated for the treatment of tension headache (migraine).

    Mayne Pharma will distribute the drug on behalf of its partner, Mikart, which developed the product and also is manufacturing the product.

  • Report: Mylan CEO calls on generics makers to ‘own the story of savings’
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