• FDA Approves Teva's CML Drug

    • 26 October 2012
    US regulators have approved Teva Pharmaceuticals' chronic myelogenous leukemia (CML) drug, Synribo (omacetaxine mepesuccinate), the second approval for a CML drug by FDA in as many months. As with Pfizer's CML drug, Bosulif (bosutinib), Synribo was approved with an orphan drug designation. Approximately 5,400 patients are expected to be diagnosed with CML, a cancer affecting the body's production of white blood cells, each year, FDA said. Drugs that treat condition...
  • FDA Ordered to Approve Watson Laboratories' ANDA for Generic Actos

    • 23 October 2012
    The US Food and Drug Administration (FDA) has been ordered to immediately approve an abbreviated new drug application (ANDA) submitted to the agency by Watson Pharmaceuticals, marking what some analysts are calling a rare defeat for the agency's regulatory discretion. The case, decided by US District Court of Washington, DC, Judge Amy Berman Jackson, regarded the diabetes medication Actos (pioglitazone), one of the most prescribed drugs in the US. Watson, a generics manu...
  • Consumers Warned of Fake Adderall in US

    The US Food and Drug Administration (FDA) warned consumers on 29 May of counterfeit copies of Teva Pharmaceutical Industries' attention deficit hyperactive disorder (ADHD) drug Adderall, saying some consumers had obtained copies of the drug containing the incorrect active pharmaceutical ingredients (APIs) through an online pharmacy. ADHD drugs like Adderall use a combination of APIs known as amphetamine salts. In the case of Adderall, the drug contains dextroamphetamine ...
  • FDA Approves Generic Lexapro

    The US Food and Drug Administration (FDA) today approved Israeli pharmaceutical manufacturer Teva Pharmaceutical Industries to legally market generic Lexapro for depression and generalized anxiety disorder in adults. Teva has been granted 180 days of marketing exclusivity, during which FDA is not allowed to approve any other generic version of Lexapro, originally manufactured by Forest Laboratories. Teva's Abbreviated New Drug Application (ANDA) for Lexapro was original...
  • Pendergast, Pitts: Sebelius' Decision on Plan B Political, Step Down a 'Slippery Slope'

    Mary Pendergast, former US Food and Drug Administration (FDA) Deputy Commissioner under President Clinton, and Peter Pitts, the former FDA Associate Commissioner under President George W. Bush, offered scathing critiques of Secretary of Health and Human Services Secretary Kathleen Sebelius during an interview on 1 January 2012. Appearing on WUSA9's BioCenturyTV , Pendergast called the recent decision by Sebelius to overrule the FDA's decision in favor of less restrictiv...