Tuesday, April 15, 2014

Massachusetts asks judge to uphold emergency ban on painkiller.

The Boston Globe (4/14, 1.62M) reports that an attorney for Massachusetts “urged a federal judge Monday to uphold the state’s emergency ban on Zohydro, a powerful, controversial painkiller, saying the state has the authority to regulate drugs coming into its market to confront a growing opiate addiction epidemic.” No other state “is believed to have banned a drug that has been approved by the US Food and Drug Administration,” but Jo Ann Shotwell Kaplan “argued that this is an ‘unusual’ case in which the FDA has approved a drug that has been opposed by 29 states. And, she said, the FDA’s own scientific advisory panel voted 11-2 against the drug’s approval. ‘A majority of the states weighed in on this, and said, “Don’t approve this,”’ said Kaplan, an assistant attorney general, adding that, ‘for that combination of states to coalesce is fairly unusual.’” Steven P. Hollman, an attorney for the drug’s maker, Zogenix, “argued that the state cannot put new restrictions on a drug that has already been approved by the federal agency responsible for making that decision.”

Indian drug maker recalls 10,000 bottles of antibacterial drugs.

The Wall Street Journal (4/15, Machado, Subscription Publication, 5.51M) reports that the US unit of Indian drug maker Lupin Ltd. is recalling thousands of bottles of antibacterial drugs which failed to meet FDA standards for impurities. The paper notes that the recall was actually initiated on Jan. 27 but made public by the FDA only this week. The latest recall is for Lupin’s cefixime, an antibiotic which is used to treat bacterial infections of the ear and upper respiratory tract.

        Reuters (4/15) reports that the FDA classified the incident as a Class III recall, meaning use of or exposure to the drug is unlikely to cause any adverse health effects. 

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