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Regulatory and Washington

  • Octapharma USA to reintroduce immune disorder drug

    HOBOKEN, N.J. — The Food and Drug Administration has cleared the way for the return to market of a drug for treating immunodeficiency diseases following its recall by the manufacturer in response to patients developing internal blood clots.

  • Bill to incentivize generic use in Medicaid introduced in Congress

    WASHINGTON — A bill proposed in Congress would give states incentives for using generic drugs through the Medicaid program.

  • Op-ed: CHPA, AMA call on Congress to repeal OTC Rx-only FSA provision

    WASHINGTON — The Consumer Healthcare Products Association last week teamed up with the American Medical Association in a joint op-ed published in Roll Call that called for the repeal of the over-the-counter prescription requirement for flexible spending accounts.

  • Q&A: Prez perspective

    In September, the Generic Pharmaceutical Association announced the appointment of Ralph Neas — former president and CEO of the National Coalition on Health Care — as its new president and CEO, replacing Kathleen Jaeger, who stepped down as president and CEO of the organization in May 2010. Drug Store News recently spoke with Neas about his plans and vision for the organization and the industry as a whole.


  • FDA report: 35 new drugs approved in past year

    SILVER SPRING, Md. — The Food and Drug Administration has approved 35 new drugs over the past 12 months, the agency said Thursday.

  • FDA approves generic version of Merck's Elestat ophthalmic solution

    ALLEGAN, Mich. — The Food and Drug Administration has approved a drug made by Perrigo and PharmaForce/Luitpold Pharmaceuticals for treating eye allergies, Perrigo said.

    The FDA approved epinastine hydrochloride ophthalmic solution in the 0.05% strength. The drug is a generic version of Merck's Elestat, used to treat ocular itching related to allergic conjunctivitis.

    Annual sales for the branded version before the appearance of generics on the market were $30 million, according to Wolters Kluwer.

  • NCPA CEO issues statement on Express Scripts-Medco merger at pharmacy coalition press conference

    WASHINGTON — At a press conference organized by the Preserve Community Pharmacy Access NOW! coalition at the Capitol on Thursday morning, the National Community Pharmacists Association's CEO Douglas Hoey issued a statement regarding the proposed merger of pharmacy benefit managers Express Scripts and Medco Health Solutions, saying the deal could mean "more wasteful mail-order spending and higher price spikes for specialty drugs."

  • FDA approves Endo generic Plendil

    CHADDS FORD, Pa. — The Food and Drug Administration has approved a drug made by Endo Pharmaceuticals for high blood pressure.

    Endo announced Wednesday the approval of felodipine extended-release tablets in the 2.5-mg, 5-mg and 10-mg strengths. Endo's generic drugs division, Qualitest Pharmaceuticals, will manufacture and distribute the product.

    The drug is a generic version of AstraZeneca's Plendil extended-release tablets. Felodipine had sales of about $84 million during the 12-month period ended in June, according to IMS Health.

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