Medication Monitor

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  • December 9, 2011

    Topical oxybutynin gel 3% has received FDA approval for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency, according to a news release from Antares and Watson. The gel is available in a metered-dose pump that is applied once daily to the thigh, abdomen, upper arm, or shoulder.

    Approval was based on a 12-week, multicenter, placebo-controlled Phase III clinical study in which patients were randomized to either oxybutynin gel 3% (84 mg) or placebo. Data from this trial showed that patients treated with oxybutynin gel daily achieved steady state drug concentrations within 3 days and experienced a statistically significant decrease in overactive bladder symptoms compared with placebo. In addition, the gel was well tolerated, with the most frequently reported treatment-related adverse events being dry mouth (12.1% versus 5% with placebo), application site erythema (3.7% versus 1.0% with placebo), and application site rash (3.3% versus 0.5% with placebo).

    This new formulation is expected to launch in 2012.

  • December 6, 2011


    Treatment of adult patients with chronic immune thrombocytopenia (ITP) who have not responded adequately to corticosteroids, immunoglobulins, or splenectomy

    FDA today announced that health professionals and facilities, including pharmacists and pharmacies, no longer need to be registered in REMS programs to prescribe and/or dispense these agents. Nplate and Promacta were originally approved in 2008 with several restrictions designed to maximize the benefits and minimize the risks of therapy in the target population.

    Specific FDA actions are as follows:

    • Health professionals, hospitals, specialty care facilities, and patients are no longer required to be enrolled in the Nplate NEXUS (Network of Experts Understanding and Supporting Nplate and Patients) Program or the Promacta CARES Program to prescribe, dispense, or receive these products. Health professionals also will no longer be required to complete periodic safety forms for patients receiving Nplate or Promacta.
    • Pharmacies/pharmacists no longer are required to enroll in the Promacta CARES Program or verify prescriber and patient enrollment before dispensing Promacta.
    • The modified REMS programs will include a communication plan that will inform health professionals about the changes to the REMS and the safety risks associated with each product.


    FDA said that it has monitored specific safety risks related to both products since their approval, including bone marrow changes of collagen deposition (reticulin), higher risk for blood clots, increased risk of development of other hematologic malignancies resulting from the stimulation of bone marrow cells, worsening low blood platelet count, and the risk of bleeding shortly after discontinuing the drugs. FDA has decided that the long-term safety of Nplate and Promacta can be evaluated based on ongoing clinical trials, postapproval studies agreed to by both companies, and adverse event reports submitted to the agency.


  • November 30, 2011

    A new oral contraceptive containing levonorgestrel and ethinyl estradiol has been approved by FDA, according to a news release from Qualitest Pharmaceuticals and Endo. This new product provides a 28-day triphasic regimen that contains levonorgestrel and ethinyl estradiol tablets in three dosage-strength combinations: 0.05 mg/0.03 mg, 0.075 mg/0.04 mg, 0.125 mg/0.03 mg.

  • November 30, 2011


    Management of dyslipidemia; cardiovascular risk reduction

    The first generic versions of Pfizer’s blockbuster drug Lipitor were launched today by Watson Pharmaceuticals and Ranbaxy Laboratories, according to news releases on the Watson and FDA websites.

    The Watson product is an authorized generic version of the drug, with Pfizer manufacturing and supplying Watson with all dosage strengths of the product. Although Watson will market and distribute the product in the U.S., Pfizer will receive a share of the net sales until November 30, 2016.

    Ranbaxy's product is being manufactured by Ohm Laboratories at its New Jersey–based facility. As the first generic approved by FDA, Ranbaxy atorvastatin has a 180-day market exclusivity period. But, barring legal challenges, Pfizer's authorization of the Watson product means that two generic versions are immediately available.

    Pfizer is also taking a number of other actions to protect its market share of Lipitor, according to reports in the consumer media

  • November 23, 2011

    A sublingual formulation of zolpidem has been approved by FDA for treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep, according to a  news release  by the manufacturer. This is the first prescription sleep medication indicated for dosing in the middle of the night. The drug should not be taken if the patient has fewer than 4 hours of expected sleep remaining.

    This sublingual tablet is formulated with a bicarbonate-carbonate buffer. Dosing differs by gender, as women clear zolpidem from the body at a lower rate than men. The recommended dose for women is 1.75 mg and for men is 3.5 mg. The 1.75 mg dose is also recommended for patients over the age of 65.

    Approval was based on data from two placebo-controlled studies, a sleep laboratory study and an outpatient study, involving more than 370 patients. Treatment with zolpidem after a middle-of-the-night awakening helped patients return to sleep significantly faster than placebo. Headache, nausea, and fatigue were the most commonly reported adverse reactions in these studies.