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Generics

  • Mylan gets green light for MS Contin generic

    PITTSBURGH — Mylan has received final approval from the Food and Drug Administration for a drug designed to treat moderate to severe pain.

    Mylan said its abbreviated new drug application for morphine sulfate extended-release tablets in the 15-mg, 30-mg, 60-mg, 100-mg and 200-mg strengths was approved by the FDA. The opioid analgesic is a generic version of Purdue Pharma's MS Contin. Mylan said it is launching the product immediately.

    Morphine sulfate ER tablets had U.S. sales of approximately $173 million for the 12 months ended in June, according to IMS Health.

  • Innopharma receives FDA approval for generic Zyprexa injection

    PISCATAWAY, N.J. — A company focused on developing niche generic and specialty pharmaceutical products has received regulatory approval from the Food and Drug Administration for its version of a psychiatric drug.

    Innopharma said its abbreviated new drug application for olanzapine injection, a generic equivalent of Zyprexa injection. With this approval, Innopharma announced that it has entered an agreement with Sandoz, who will sell, market and distribute Innopharma's generic in the United States.

  • Heather Bresch promoted to CEO at Mylan

    PITTSBURGH — Generic drug maker Mylan's board of directors has approved a new management structure for the company, effective Jan. 1, 2012.

    Mylan's board approved the transition of current chairman and CEO Robert Coury to the new role of executive board chairman. With this, Mylan president Heather Bresch will become CEO and directly report to the company's board.

  • Rite Aid partners with Envision Insurance to offer Medicare Part D Rx drug plan

    CAMP HILL, Pa. — Medicare Part D beneficiaries will be able to obtain hundreds of generic drugs without any deductible or co-pay under a new program offered by Rite Aid.

    The retail pharmacy chain announced Tuesday that it had partnered with Envision Insurance Co. to offer a value-focused prescription drug plan for Medicare Part D Open Enrollment 2012. Rite Aid EnvisionRx Plus offers beneficiaries a plan with a $0 deductible and $0 co-pays, including during the coverage gap, also known as the donut hole.

  • Lannett gets OK for generic anti-obesity drug

    PHILADELPHIA — Lannett has received approval from the Food and Drug Administration to market its version of an anti-obesity drug.

    The FDA approved Lannett's abbreviated new drug application for diethylpropion hydrochloride extended-release tablets in the 75-mg strength. The company expects to begin shipping the product immediately.

  • FTC staff report attacks branded-generic patent settlements

    WASHINGTON — The Federal Trade Commission released a report Tuesday finding that drug companies entered 28 deals that the FTC called anticompetitive and said would increase healthcare costs for consumers and the government.

    The FTC, which under the leadership of chairman Jon Leibowitz, repeatedly has attacked what it calls "pay-for-delay" deals between branded and generic drug manufacturers and has been lobbying the Congressional Joint Select Committee on Deficit Reduction, also known as the super committee, to ban the deals.

  • Sales, profits increase for Dr. Reddy's in Q2

    HYDERABAD, India — Dr. Reddy's Labs reported sales of $462 million for second quarter 2012 and $866 million for the first half of the fiscal year, according to an earnings statement released Tuesday.

    The Indian generic drug maker said the second-quarter sales represented a 21% increase over second quarter 2011. Sales from global generics were $329 million for the quarter, an 18% increase over second quarter 2011, driven mostly by growth in North America and Russia.

    Profits for the quarter were $63 million, a 7% increase over second quarter 2011.

  • FDA approves generic versions of Zyprexa

    SILVER SPRING, Md. — The Food and Drug Administration has approved the first generic versions of two drugs made by Eli Lilly for treating schizophrenia and bipolar disorder, the agency said Monday.

    The FDA announced the approval of generic olanzapine tablets and olanzapine orally disintegrating tablets, respectively generic versions of Lilly's Zyprexa and Zyprexa Zydus. Dr. Reddy's Labs and Teva Pharmaceuticals USA will manufacture olanzapine tablets, while Dr. Reddy's, Apotex and Par Pharmaceuticals will manufacture the orally disintegrating version.

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