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New Products

  • GSK's, Theravance's Anoro Ellipta receives FDA approval

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by GlaxoSmithKline and Theravance for treating chronic obstructive pulmonary disease, the agency said Wednesday.

    The FDA announced the approval of Anoro Ellipta (umeclidinium; vilanterol inhalation powder) as a once-per-day maintenance treatment for airflow obstruction in patients with COPD, a term that encompasses chronic bronchitis and emphysema; smoking is the leading cause of COPD in the United States.

  • Actelion launches Valchlor

    SOUTH SAN FRANCISCO, Calif. – Actelion has launched a topical gel used to treat a kind of skin cancer, the company said.

    Actelion announced the launch of Valchlor (mechlorethamine), which the Food and Drug Administration approved in August for treating stage 1A and 1B mycosis fungoides-type cutaneous T-cell lymphoma in patient who have received skin-directed therapy before. Actelion acquired rights to the drug when it merged with Ceptaris Therapeutics. Accredo Specialty Pharmacy distributes the drug in the United States.

  • Lupin launches generic HIV drug

    BALTIMORE — Lupin has launched a generic drug for treating HIV, following its victory in a patent-infringement suit in federal court, the Indian drug maker said Wednesday.

    Lupin's U.S. subsidiary launched its generic version of ViiV Healthcare's Trizivir (abacavir sulfate; lamivudine; zidovudine) tablets in the 300-mg/150-mg/300-mg strength. The launch follows a ruling by the U.S. District Court for the District of Delaware that the drug did not infringe on Viiv's patent.

  • Sibu launches Omega 7 product

    SALT LAKE CITY — Sibu Beauty, a skin care and supplement line made from the sea buckthorn berry, announced the Sibu Seven Omega 7 Pure Line. The product boasts the most potent, natural form of omega-7 (palmitoleic acid), the company said.

  • Amneal launches new GERD treatment

    BRIDGEWATER, N.J. — Amneal Pharmaceuticals has launched a new treatment for gastroesophageal reflux disease under a partnership with a South Korean drug maker.

    Amneal announced Tuesday the launch of esomeprazole strontium delayed-release capsules in the 49.3-mg strength, which it is marketing in the United States under a contract with Hanmi Pharmaceutical Co. The drug is expected to begin shipping Wednesday in 30-count bottles.

  • Greenstone launches authorized generic voriconazole for oral suspension

    PEAPACK, N.J. — Greenstone has launched a version of a drug used to treat fungal infections, the company said.

    Greenstone, the generics subsidiary of Pfizer, announced the introduction of voriconazole for oral suspension, an authorized generic version of Pfizer's Vfend. Authorized generics are branded drugs sold at a discount under their generic names.

    Greenstone is selling the drug in the 40 mg-per-milliliter strength. Vfend had sales of about $17.1 million during the 12-month period that ended in June, according to IMS Health.

     

  • Mylan, Banner settle cancer drug lawsuit with Eisai, Valeant

    PITTSBURGH — Mylan and a partnering company will be able to sell a generic version of a cancer drug starting in summer 2015, under a court settlement announced Tuesday.

    Mylan said that it and Banner Pharmacaps had reached a settlement agreement with Eisai and a subsidiary of Valeant Pharmaceuticals International to resolve a lawsuit filed over their generic version of Targretin (bexarotene) capsules in the 75-mg strength. The drug is used to treat certain forms of T-cell lymphoma.

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