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    FDA Proposes to Withdraw Two Generic Versions of ADHD Drug Concerta

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday proposed withdrawing two generic versions of Janssen’s extended-release attention deficit hyperactive disorder (ADHD) drug Concerta (methylphenidate hydrochloride) two years after determining that they do not provide sufficient therapeutic effects. The manufacturers of the two Concerta generics - Kremers Urban Pharmaceuticals, a subsidiary of the Lannett Company, and Ma...
  • FDA Gives More Time to Generic Facilities to Register, Saying Many Have Not

    The US Food and Drug Administration (FDA) is delaying by two weeks the implementation of its facility registration requirements under the Generic Drug User Fee Act (GDUFA) , a subset of a recently passed FDA Safety and Innovation Act (FDASIA) . One of the law's main goals was to achieve parity between the way FDA collects fees from branded and generic pharmaceutical products. Under a long-standing program, FDA assesses user fees from branded pharmaceutical companies ...
  • EMA Releases Draft Guidelines on Oral Modified Release Products and Transdermal Patches

    The European Medicines Agency (EMA) has released two new draft guidelines on, respectively, the quality of oral modified release products and transdermal patches. The two draft guidance documents replace an earlier Note for Guidance on both topics released in July 1999.  Oral Modified Release Products The first guideline, Draft guideline on quality of oral modified release products , describes how Marketing Authorization Applications (MAAs) should address ...