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Generics

  • FDA issues guidelines for prospective makers of generic asthma, COPD drug

    NEW YORK — A new set of guidelines from the Food and Drug Administration could bring a generic version of a respiratory drug made by GlaxoSmithKline closer to reality.

    The FDA guidelines, a set of non-binding recommendations released Monday, outline studies that manufacturers can conduct to determine equivalence between GSK's Advair Diskus (fluticasone propionate; salmeterol xinafoate) and generic versions.

  • Upsher-Smith launches morphine sulfate capsules

    MAPLE GROVE, Minn. — A new opioid painkiller drug made by Upsher-Smith Labs will become available on Wednesday, the drug maker said.

    Upsher-Smith said it would launch its morphine sulfate extended-release capsules in the 10-mg, 20-mg, 30-mg, 50-mg, 60-mg, 80-mg and 100-mg strengths.

    The company said its product would be the first generic entrant for the 10-mg extended-release capsule dosage strength, adding that there have historically been a limited number of morphine sulfate generics available.

     

  • Study questions drug-discount programs

    NEW YORK — Over the last few years, many drug makers have offered coupons and co-payment-assistance programs as a way to reduce patients' out-of-pocket spending on medications, but a new study questions whether they really reduce spending in the long run and whether they're even legal.

  • Indian regulators clear $1.6 billion Mylan-Strides Arcolab deal

    PITTSBURGH — Indian regulators have approved a deal from Mylan to buy the injectables business of Strides Arcolab, Mylan said Tuesday.

    Following the approval of Agila by India's Foreign Investment Promotion Board, Mylan also received approval from the Cabinet Committee on Economic Affairs. The deal is expected to close in fourth quarter 2013. Mylan announced its plan to buy Agila for $1.6 billion in February 2013.

  • Proxy advisory firms recommend that Actavis-Warner Chilcott deal go through

    PARSIPPANY, N.J. — Three independent proxy advisory firms are recommending that Actavis shareholders vote in favor of the company's proposed acquisition of Warner Chilcott.

    Actavis said Thursday that Institutional Shareholder Services, Glass Lewis and Egan-Jones had issued the recommendation regarding the $8.5 billion acquisition of Ireland-based Warner Chilcott, announced in May.

  • Study uncovers new groups at risk of influenza complications — new moms and obese people

    HAMILTON, Ontario — New mothers and obese people, two groups not typically regarded as risk groups, were found to have a higher risk of death and other severe outcomes from influenza, according to a global study sponsored by the World Health Organization that was released Tuesday.

  • Reports: FDA says carve-out bills 'undermine trust' in biosimilars

    NEW YORK — The Food and Drug Administration is concerned about bills in several state legislatures that seek to restrict pharmacists' ability to dispense biosimilars, according to published reports.

    Biopharma-Reporter.com quoted an FDA spokeswoman as saying "efforts to undermine trust in these products" were cause for worry and did not serve the interests of patients.

  • BD wins approval for generic, injectable antiemetic

    FRANKLIN LAKES, N.J. — The Food and Drug Administration has approved the latest drug in BD's Simplist line, the company said Thursday.

    BD announced the approval of ondansetron injection in the 4 mg/2 mL strength, an injectable drug used to prevent nausea and vomiting after surgery. The drug is currently on the FDA's drug shortage list due to recent increases in demand and supply issues faced by other manufactures, BD said.

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