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Generics

  • Endo integrates business units, plans name change

    CHADDS FORD, Pa. — Endo's parent company is looking to change its name and will integrate four of its operating units, the drug maker said Thursday.

    Endo said the company, currently called Endo Pharmaceutical Holdings, would ask shareholders to approve changing the name to Endo Health Solutions at its annual shareholder meeting in May.

  • Federal court upholds DEA action against Cardinal Health

    COLUMBUS, Ohio — A federal court has turned down Cardinal Health's request for an injunction against the Drug Enforcement Administration's suspension of the its ability to ship controlled medications from one of its distribution centers, the company said Wednesday.

    Reggie Walton, a judge for the U.S. District Court for the District of Columbia, ruled against Cardinal's request to enjoin the DEA from preventing the company from shipping controlled substances from the distribution center, in Lakeland, Fla.

  • FDA approves Hi-Tech Pharmacal epilepsy drug

    AMITYVILLE, N.Y. — The Food and Drug Administration has approved a drug for epilepsy made by Hi-Tech Pharmacal, the drug maker said Wednesday.

    Hi-Tech announced the approval of levetiracetam oral solution in the 100 mg-per-milliliter strength. The drug is a generic version of UCB Pharma's Keppra oral solution and is used to treat partial onset seizures in people ages 16 years and older.

    Various versions of the drug had sales of $62 million in 2011, according to IMS Health. Hi-Tech said it plans to launch the drug in May.

  • Mylan launches generic version of Forest Labs' Lexapro

    PITTSBURGH — Mylan has launched a generic drug for treating depression and anxiety, the company said Wednesday.

    Mylan announced the launch of escitalopram tablets in the 5-mg, 10-mg and 20-mg strengths, the first generic version of Forest Labs' Lexapro. The drug is used for treating major depressive disorder and generalized anxiety disorder.

  • Statins could increase blood sugar, cause cognitive problems, FDA says

    SILVER SPRING, Md. — Drugs widely used to treat cholesterol may cause increases in blood sugar and other symptoms, the Food and Drug Administration said Tuesday.

  • FDA exploring how to expand eligible Rx-to-OTC switches by utilizing pharmacy

    SILVER SPRING, Md. — The Food and Drug Administration on Tuesday announced it will hold a public hearing on March 22 and 23 to discuss how technology can expand which drug products can be switched from prescription to over-the-counter status.

  • Glenmark recalls seven lots of contraceptive drug

    NEW YORK — The U.S. unit of Indian generic drug maker Glenmark is recalling a generic contraceptive drug, the company said.

    Glenmark Generics USA announced the recall of seven lots, imported from India, of norgestimate and ethinyl estradiol tablets in the 0.18-mg/0.035-mg, 0.215-mg/0.035-mg and 0.25-mg/0.035-mg strengths. The company said a packaging error resulted in blister packs being rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiration date visible only on the outer pouch.

  • Report: Court OKs agreement between GSK, Apotex over generic Paxil CR

    NEW YORK — GlaxoSmithKline can sell an authorized generic of its antidepressant drug to Toronto-based drug maker Apotex, a U.S. judge ruled.

    According to a Bloomberg Businessweek report, U.S. District Court judge Joe Pisano ruled the agreement was valid.

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