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Regulatory and Washington

  • Mylan gets go-ahead for generic Effexor XR

    PITTSBURGH — The Food and Drug Administration has approved a generic drug for depression and anxiety made by Mylan, the drug maker said Thursday.

    Mylan announced the approval of venlafaxine hydrochloride extended-release capsules in the 37.5-mg, 75-mg and 150-mg strengths.

    The drug, used to treat major depressive disorder and social anxiety disorder, is a generic version of Effexor XR, made by Wyeth. Mylan is launching the drug under a licensing agreement it made with Wyeth before its purchase by Pfizer.

  • Food pyramid changing shape

    WASHINGTON — It seems that the Obama administration is looking to replace the food pyramid, which has provided Americans with dietary guidelines for nearly two decades.

  • Sandoz gets green light for two generic Alzheimer's disease drugs

    PRINCETON, N.J. — Sandoz has launched generic versions of treatments for Alzheimer’s disease, the generic pharmaceuticals division of Swiss drug maker Novartis said Wednesday.

    Sandoz announced the launch of donepezil hydrochloride film-coated tablets and donepezil hydrochloride orally disintegrating tablets, which are generic versions of Eisai and Pfizer’s Aricept and Aricept ODT, respectively.

    Donepezil hydrochloride film-coated and orally disintegrating tablets had sales of $2.3 billion in the 12-month period ended in March, according to IMS Health.

  • XTL granted orphan drug designation for multiple myeloma treatment

    HERZLIYA, Israel — The Food and Drug Administration has given orphan drug designation to an investigational treatment for multiple myeloma, a blood cell cancer, that soon will enter mid-stage development.

    XTL announced that the FDA had granted the designation to its recombinant human erythropoietin, or rHuEPO drug, for which the company soon will start phase-2 clinical trials.

    The FDA gives orphan drug designation to treatments for diseases that affect fewer than 200,000 people in the United States per year.

  • FDA to examine possible link between drospirenone, blood clots risk

    SILVER SPRING, Md. — The Food and Drug Administration is investigating a possible link between a class of birth control pills and a higher risk of blood clots in the women taking them, the agency said.

  • Actavis' generic Aricept gets FDA nod

    MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic treatment for Alzheimer’s disease made by Actavis, the drug maker said Tuesday.

    The FDA approved the company’s donepezil hydrochloride tablets in the 5-mg and 10-mg strengths, a generic version of Eisai and Pfizer’s Aricept. Donepezil hydrochloride tablets in the two strengths had sales of about $2.3 billion during the 12-month period ended in March, according to IMS Health.

  • NCPA's Keith Hodges discusses pharmacy robberies, Rx abuse in CNN segment

    ALEXANDRIA, Va. — As part of a series on prescription drugs in America, CNN’s “American Morning” program on Wednesday hosted Safeguard My Meds spokesman and National Community Pharmacists Association executive committee member Keith Hodges to discuss pharmacy robberies and prescription drug abuse in a segment called “Pharmacies as Targets.”

    “Prescription drug use is on the rise, especially over the last 10 to 15 years, and pharmacies are an easy target,” Hodges told CNN reporter Kiran Chetry.

  • House passes Defense Authorization bill; Tricare Prime fees to increase

    ALEXANDRIA, Va. — The House of Representatives last week passed the FY2012 Defense Authorization bill by a vote of 322 to 96. The bill includes a small increase in the Tricare Prime fee, the American Society of Military Comptrollers noted in a statement, but caps future increases at no more than the cost-of-living adjustment.

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