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Regulatory and Washington

  • Deloitte: Consumers turn to various resources for recall information

    NEW YORK — Consumers that seek timely and detailed information about product recalls look to multiple resources, according to a new Deloitte survey.

  • Taro receives FDA approval for generic Aldara

    HAWTHORNE, N.Y. — The Food and Drug Administration has approved a topical treatment for skin conditions made by Israeli generic drug maker Taro Pharmaceutical Industries.

    Taro announced Monday the approval of imiquimod cream in the 5% strength. The drug is used to treat actinic keratosis and external genital warts, and is a generic version of Graceway Pharmaceuticals’ Aldara.

    Imiquimod cream has annual sales of around $340 million in the United States, according to Taro.

  • CDC experts spotlighted in 'Killer Outbreaks'

    ATLANTA — The Centers for Disease Control and Prevention is participating in a new docudrama that debuts on Animal Planet beginning Friday at 9 p.m., the agency announced earlier this week.

    Animal Planet has ordered six episodes of the new series “Killer Outbreaks.” Each episode features potentially deadly viruses and includes commentary from CDC experts and victims of the outbreaks. "Killer Outbreaks" began production in March 2010, and in total, producers interviewed 43 subject matter experts from across the agency.

  • PhRMA honors scientists that helped discover Januvia

    JERSEY CITY, N.J. — The main trade group representing branded drug makers gave an award to two Merck scientists who helped discover an oral medication for Type 2 diabetes.

  • Takeda's Edarbi enters market

    DEERFIELD, Ill. — Takeda Pharmaceutical has launched a new treatment for high blood pressure, the company said Friday.

    Takeda announced the launch of Edarbi (azilsartan medoxomil), which the Food and Drug Administration approved on Feb. 25 as a once-daily pill for hypertension.

  • Abbott Diagnostics seeks FDA approval for vitamin D assay

    ABBOTT PARK, Ill. — Abbott Diagnostics on Friday announced its filing of a submission for clearance by the Food and Drug Administration for a fully automated vitamin D assay performed on its Architect testing system for use by healthcare professionals.

    "Increasing interest in vitamin D is fueling a surge in orders for tests as more healthcare professionals and consumers become aware of the rising prevalence of vitamin D deficiencies in otherwise healthy people and the potential health risks," stated Sudarshan Hebbar, senior medical director of Abbott Diagnostics.

  • Dr. Reddy's announces market launch of generic OTC Allegra

    HYDERABAD, India — The Food and Drug Administration has approved Dr. Reddy's version of an allergy medication that recently received Rx-to-OTC switch approval, the generic drug maker said.

    Dr. Reddy's fexofenadine HCl tablets are bioequivalent versions of Sanofi-Aventis’ Allegra, which received Rx-to-OTC switch approval from the FDA in January.

    The fexofenadine HCl Rx market had branded and generic sales of approximately $452 million for the 12 months ended last December, according to IMS Health.

  • NCPA: Pharmacists can help combat Rx drug abuse

    ALEXANDRIA, Va. — Local pharmacists work with patients and law enforcement to combat the abuse of controlled substances and other prescription drugs, but changes to federal policy are needed to allow pharmacists to play a greater role, the National Community Pharmacists Association suggested Thursday in comments submitted to Congress.

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