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Generics

  • Merck Manual professional app update makes mobile reference guide free
    KENILWORTH, N.J. — A new update to the mobile app for the Merck Manual for Healthcare Professionals is broadening access to the reference guide. Merck announced Thursday that with the latest update, the app is entirely redesigned and free. Once the app is downloaded, its content is saved offline so it can be accessed with or without an Internet connection. 
     

  • Lupin gets tentative approval on Avelox generic
    SILVER SPRING, Md. — The Food and Drug Administration has given Lupin’s U.S. arm, Gavia Pharmaceuticals, a tentative approval for its generic of Avelox (moxifloxacin HCl) tablets, the company announced Tuesday. 
     
    The drug will be available from Lupin in 400-mg dosage strength, and the product had U.S. sales of $30.1 million for the 12 months ended June 2016, according to IMS Health data. 
     

  • Dr. Reddy's launches generic Wellbutrin SR
    HYDERABAD, India and PRINCETON, N.J. — Dr. Reddy’s Laboratories announced Friday the U.S. launch of its generic of Wellbutrin SR (bupropion HCl) extended-release tablets. 
     
    Brand and generic sales of the drug were $109.6 million for the 12 months ended July 2016, according to IMS Health. The Dr. Reddy’s generic will be available in 60-, 100- and 500-count bottles in 100-, 150- and 200-mg dosage strengths. 
     

  • FDA gives tentative approval to Perrigo’s generic Epiduo Gel
    SILVER SPRING, Md. — The Food and Drug Administration has given its tentative approval for Perrigo’s generic of Epiduo Gel (adapalene and benzoyl peroxide 0.1%/2.5%), the company announced Thursday. The drug is indicated to treat acne vulgaris in patients 12 years of age and older. 
     
    Annual sales for the product were $379 million for the 12 months ended July 2016. 
     

  • FDA reaches agreement with generics industry on new GDUFA commitments

    WASHINGTON — The Food and Drug Administration and the generic drug manufacturing industry —including representatives of generic pharmaceutical manufacturers, active pharmaceutical ingredient manufacturers and contract manufacturing organizations — have reached agreement on a package of program enhancements and resource commitments to reauthorize the Generic Drug User Fee Amendments of 2012 (GDUFA), which are set to expire next year.

  • FDA warns against combined use of opioids and benzodiazepines

    SILVER SPRING, Md. - The U.S. Food and Drug Administration announced Wednesday that it is requiring class-wide changes to drug labeling, including patient information, for almost 400 products to help inform health care providers and patients of the serious risks associated with the combined use of certain opioid medications and a class of central nervous system depressant drugs called benzodiazepines.

  • Report: FTC taking closer look at M&As concerning generic pharmaceuticals

  • Report: Biosmilar regulatory pathway promising but there are sill barriers
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