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Generics

  • Mylan's generic Xalatan receives regulatory approval

    PITTSBURGH — The Food and Drug Administration has approved a generic drug made by Mylan that reduces pressure in the eye, Mylan said Monday.

    Mylan announced the approval of latanoprost ophthalmic solution in the 0.005% strength. The drug is a generic version of Xalatan, made by Pharmacia and Upjohn, now part of Pfizer.

    Various versions of the drug had sales of around $711 million in 2010, according to IMS Health.

  • Impax says Parkinson's disease treatment is safe, effective

    HAYWARD, Calif. — An investigational drug for Parkinson’s disease was safe and effective, according to results of a late-stage clinical trial scheduled for presentation next week.

    Impax Pharmaceuticals, the branded products division of Impax Labs, said it would present data from a phase-3 trial of extended-release IPX066 (carbidopa-levodopa) at the American Academy of Neurology Conference’s annual meeting in Hawaii, which takes place from April 9 through April 16.

    The company also said there were no unexpected serious side effects observed in patients.

  • Watson receives FDA approval for Nulecit

    MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic treatment for iron deficiency anemia made by Watson Pharmaceuticals, Watson said Thursday.

    The drug maker announced the approval of Nulecit (sodium ferric gluconate complex in sucrose), an injectable and generic version of Sanofi-Aventis’ Ferrlecit.

    The drug is used to treat iron deficiency anemia in adults and children ages 6 years and older undergoing chronic hemodialysis and receiving supplemental epoetin therapy.

  • Aurobindo receives approval for generic Razadyne, Monopril

    HYDERABAD, India — Indian generic drug maker Aurobindo has received two approvals from the Food and Drug Administration.

    The company said Wednesday that it received approval for galantamine tablets in the 4-, 8- and 12-mg strengths. The drug is a version of Johnson & Johnson’s Alzheimer’s treatment Razadyne; various versions of the drug had sales of $41 million during the 12 months ended in September 2010, according to IMS Health.

  • Report: Generic utilization can save Medicaid millions

    WASHINGTON — The American Enterprise Institute for Public Policy Research on Monday published a working paper that identified $329 million in overspending as a result of underutilization of generics.

    As total spending on 20 medicines with generic equivalents totaled approximately $1.5 billion, AEI concluded Medicaid overspent by 22% ($1.5 billion versus $1.17 billion) on these pharmaceuticals.

  • Dr. Reddy's completes acquisition of U.S. penicillin facility, products from GSK

    HYDERABAD, India — Dr. Reddy’s Labs will assume ownership of a penicillin manufacturing site in Bristol, Tenn., from GlaxoSmithKline.

    The generic drug maker said it completed the acquisition of the facility and related product portfolio, including Augmentin and Amoxil brands. GSK will retain the existing rights for the aforementioned brands outside the United States.

    Further financial terms and conditions of the transaction are not being disclosed.

  • Drug shortages continue to rise, report finds

    NEW YORK — For many patients, the inability to pay for drugs is enough of a problem, but what if the drugs they need aren’t available at all?

    According to a new report by the Premier Healthcare Alliance, more than 240 drugs were hard to find or entirely unavailable, while more than 400 generic versions of branded drugs were backordered for more than five days. Premier said shortages had more than tripled since 2005, with the frequency and effects rising to critical levels and affecting all segments of health care.

  • Dr. Reddy's generic Xyzal hits market

    HYDERABAD, India — Indian generic drug maker Dr. Reddy’s Labs has launched a generic treatment for seasonal allergies, the company said Tuesday.

    Dr. Reddy’s announced the launch of levocetirizine tablets in the 5-mg strength. The drug is a generic version of UCB’s and Sanofi-Aventis’ Xyzal.

    Levocetirizine had sales of about $238 million during the 12-month period ended in September 2010, according to IMS Health.

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