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  • Merck drug approved for preventing fungal infections in immunosuppressed patients

    WHITEHOUSE STATION, N.J. — The Food and Drug Administration has approved a new tablet form of an antifungal drug made by Merck, the company said Tuesday.

    Merck announced the FDA approval of Noxafil (posaconazole) 100-mg delayed release tablets. The company also markets a 40-mg-per-milliliter oral suspension form of the drug. The new tablet formulation is designed to be taken in two 300-mg doses on the first day, followed by a 300-mg dose once per day.

  • FDA to allow dispensing of GSK's Type 2 diabetes drug Avandia in retail pharmacies again

    SILVER SPRINGS, Md. – Federal regulators are lifting some restrictions on a diabetes drug that were placed two years ago after studies linked the drug to increased cardiovascular risk.

  • FDA approves J&J's Olysio for hepatitis C

    TITUSVILLE, N.J. — The Food and Drug Administration has approved a new treatment made by Johnson & Johnson for hepatitis C, the drug maker said.

  • Sandoz launches authorized generic version of PharmaDerm's Solaraze

    PRINCETON, N.J. — Sandoz has launched an authorized generic version of a topical drug for treating actinic keratosis, the company said.

    Sandoz, the generics arm of Swiss drug maker Novartis, announced the launch of authorized generic diclofenac gel in the 3% strength. The drug is a version of PharmaDerm's Solaraze.

  • FDA approves Bayer's Nexavar for thyroid cancer

    SILVER SPRING, Md. – The Food and Drug Administration has approved a drug made by Bayer HealthCare Pharmaceuticals for treating thyroid cancer, the agency said Friday.

    The FDA announced the approval of Nexavar (sorafenib) to treat late-stage differentiated thyroid cancer. The drug was already approved for kidney and liver cancers. The drug works by limiting cancer cell growth and replication by inhibiting proteins within the cells.

  • FDA gives regular approval to Pfizer's Xalkori

    NEW YORK — The Food and Drug Administration has granted regular approval to a new drug made by Pfizer for treating a form of lung cancer, the drug maker said.

  • Diplomat added to limited-distribution network for Cornerstone Therapeutics' Bethkis

    FLINT, Mich. — Cornerstone Therapeutics has added specialty pharmacy Diplomat to its limited-distribution network for a newly approved treatment for cystic fibrosis, Diplomat said Friday.

    Diplomat will distribute Bethkis (tobramycin inhalation solution), which received Food and Drug Administration approval in October for treating chronic bacterial lung infections caused by P. aeruginosa in cystic fibrosis patients.

  • FDA wants more clinical trial data before approving Forest, Gedeon Richter psychiatric drug

    NEW YORK — The Food and Drug Administration has declined to approve an experimental drug for schizophrenia and bipolar disorder developed by Forest Labs and Gedeon Richter, a Hungarian drug company, the two said Thursday.

    The companies said the FDA issued a complete-response letter for cariprazine. The agency issues a complete-response letter when it has finished reviewing an application but issues remain that preclude final approval. In the letter, the FDA acknowledged the drug's efficacy, but wanted more clinical trial data.

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