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Generics

  • Yabao, Salus announce generics partnership
    BEIJING and MONMOUTH JUNCITON, N.J. — Yabao Pharmceutical Co. and Salus Pharma recently announced a partnership through which the two will co-develop, manufacture and commercialize generics with a high technological barrier. 
     
    Under the partnership, Yabao will own commercialization rights outside the U.S. on certain products developed by Salus Pharma, and Salus will have commercialization rights in the U.S. The companies did not disclose financial terms of the partnership.
     

  • Researchers find four supplements that boost efficacy of antidepressants
    PARKVILLE, Australia - An international evidence review has found that certain nutritional supplements can increase the effectiveness of antidepressants for people with clinical depression.
     
    Omega 3 fish oils, S-adenosylmethionine (SAMe), methylfolate (bioactive form of folate) and vitamin D, were all found to boost the effects of medication.
     

  • Perrigo names new CEO following departure of Joseph Papa
    DUBLIN - Perrigo on Monday announced the appointment of John Hendrickson as CEO, effective immediately, following the resignation and departure of Joseph Papa.
     

  • FDA approves Aurobindo’s generic Nexium
    SILVER SPRING, Md. — Aurobindo Pharma announced recently that it had received approval from the Food and Drug Administration for its generic Nexium (esomeprazole magnesium) delayed-release capsules. The drug is indicated to treat gastroesophageal reflux disease. 
     
    Aurobindo’s generic will be available in 20- and 40-mg dosage strengths. The drug had an estimated market size of about $4.2 billion for the 12 months ending February 2016, according to IMS Health. 
     

  • Lupin launches generic Femhrt
    BALTIMORE —  Lupin announced this week that it had launched its Fyavolv tablets, a generic of Femhrt (norethindrone acetate and ethinyl estradiol). The drug is indicated to treat moderate to severe menopause-related vasomotor symptoms and to prevent postmenopausal osteoporosis. 
     
    The drug had U.S. sales of about $39 million for the 12 months ended December 2015, according to IMS Health. 

     

  • New spending bill looks to push FDA on generics naming guidelines
    WASHINGTON —  The House Appropriations Committee on Friday released a new spending bill for the coming fiscal year, which provides additional funding for the FDA and contains language about how the Food and Drug Administration should finalize its guidance on generic drug and biosimilar naming. 
     

  • FDA: 2015 saw record generics approvals, OGD on track with GDUFA goals
    SILVER SPRING, Md. — The year 2015 saw the highest number of approvals and tentative approvals of generic drugs ever at the Food and Drug Administration according to a new report released by the Office of Generic Drugs. 
     

  • Congress passes Ensuring Patient Access Act
    ARLINGTON, Va. – The U.S. House of Representatives on Tuesday passed the Ensuring Patient Access and Effective Drug Enforcement Act of 2016 (S. 483) in the same version passed by the Senate, making President Obama’s consideration and signature the final step before enactment.
     
    The legislation, advocated by both retail pharmacy and the pharma industry, would advance collaboration among health and enforcement authorities to achieve drug abuse solutions that maintain patients’ legitimate access to medications.
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