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  • Allergan, Adamas announce new Namzaric dosage strengths availability

    DUBLIN and EMERYVILLE, Calif. —Allergan and Adamas Pharmaceuticals on Thursday announced the availability of all four dosage strengths of its Namzaric (memantine and donepezil hydrochloride) extended-release capsules. 
     
    Namzaric is a fixed-dose combination of memantine and 10 mg donepezil hydrochloride indicated to treat moderate to severe Alzheimer’s disease in patients stabilized on 10 mg of donepezil hydrochloride. The Food and Drug Administration approved the drug in July. 
     
  • PhRMA brings scientists to Capitol Hill

    WASHINGTON — The Pharmaceutical Research and Manufacturers of America (PhRMA) on Wednesday brought 60 of its member companies’ researchers to Capitol Hill for meetings with members of Congress. The researchers will discuss with lawmakers how they can support developing new, innovative medicines. 
     
  • FDA approves Janssen’s Invokamet XR

    SILVER SPRING, Md. — The Food and Drug Administration has approved Janssen Pharmaceuticals’ Invokamet XR, a once-daily, extended-release combination therapy of Invokana (canagliflozin) and metformin, the company announced Wednesday. The drug is indicated as a first-line treatment to improve blood glucose control in adults with Type 2 diabetes alongside diet and exercise. 
     
  • FDA approves low-dose appetite suppressant Lomaira

    SILVER SPRING, Md. — The Food and Drug Administration has approved KVK Tech’s Lomaira (phentermine HCl), the company announced Tuesday. The drug is indicated for short-term use to aid in weight reduction in obese and overweight patients (patients with body mass indices of 30 or higher and 27 or higher, respectively) with at least one weight-related condition, including high blood pressure and diabetes. 
     
  • FDA advisory committees recommend removing Chantix boxed warning

    SILVER SPRING,  Md. — The Food and Drug Administration’s advisory committees on psychopharmacologic drugs and drug safety risk management held a recommended Wednesday that the boxed warning accompanying Pfizer’s smoking cessation drug Chantix be removed. 
     
  • FDA approves Shire’s Cuvitru

    LEXINGTON, Mass. — The Food and Drug Administration has approved Shire’s latest treatment Cuvitru (immune globulin subcutaneous (human) 20% solution). The drug is indicated to treat adults and pediatric patients ages two years and older with primary immunodeficiency, a group of more than 300 genetic disorders in which a part of the immune system functions improperly or is missing. 
     
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