Medication Monitor

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Generic Name (Trade Name—Company)
  • August 13, 2011


    Management of HIV-1 infection in treatment-naive patients

    Gilead announced the FDA approval of its single-tablet, once-daily regimen for treatment of HIV-1 infection in treatment-naive adults. Complera contains emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir 300 mg and is taken once daily with a meal.

    Approval was based on data from two previously conducted Phase III randomized studies, ECHO and THRIVE, of rilpivirine, on which approval of that drug was based. No new studies were conducted for approval of this new triple combination therapy. A bioequivalence study demonstrated that the triple-drug tablet achieved the same blood levels as each of the drugs administered individually.

  • August 9, 2011


    Treatment of numerous cancers including ovarian, non-small cell lung cancer, breast, and pancreatic cancer

    Hospira announced the FDA approval of the first solution formulation of gemcitabine injection. The product, which launches in early September, will be marketed in vials that contain 200 mg, 1 g, and 2 g of drug (concentration 38 mg/mL). Previously, Hospira launched lyphophilized, or freeze-dried, preparations of the product in the same strengths.

    This new formulation eliminates the need for reconstitution.

  • August 2, 2011

    A self-injectable subcutaneous formulation of abatacept has been approved for adult patients with moderate to severe rheumatoid arthritis (RA), according to a press release from the manufacturer. The drug was originally approved as an IV infusion. Data from a Phase III, randomized, double-blind, double-dummy, multinational study involving 1,457 patients with moderately-to-severely active RA showed that subcutaneous administration of abatacept demonstrated similar efficacy and safety to the IV formulation at month 6.

    Both formulations resulted in a similar frequency of injection site reactions (2.6% subcutaneous vs. 2.5% IV), and patient retention rates were similar in both groups at 6 months (94%). The new fixed-dose 125-mg subcutaneous injection is administered weekly. Treatment-naive patients who can tolerate an infusion should receive an IV loading dose of 10 mg/kg before starting weekly injections. The product will be available in September.

  • August 2, 2011

    Teva has announced the launch of Camrese, an authorized generic version of the company's levonorgestrel/ethinyl estradiol and ethinyl estradiol (Seasonique) tablets. The product contains 91 tablets (84 tablets containing levonorgestrel 0.15 mg/ethinyl estradiol 0.03 mg and 7 tablets containing ethinyl estradiol 0.01 mg) and is indicated for prevention of pregnancy.

  • July 25, 2011


    Replacement therapy for primary humoral immunodeficiency in adult and pediatric patients 2 years of age or older

    Baxter has announced FDA approval of Gammagard Liquid 10% to be administered via the subcutaneous route for patients with primary immunodeficiency. The original approval was for intravenous administration. This new route of administration will allow patients to self-administer the product at home on a weekly basis. Clinical trial data showed that subcutaneous administration of Gammagard provided similar efficacy as intravenous administration of immune globulin, with the most frequent adverse reactions of the new route of administration being local skin site reactions (2.7%).