Medication Monitor



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Generic Name (Trade Name—Company)
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  • May 3, 2013

    InnoPharma has announced approval of cosyntropin injection, a generic of Amphastar's Cortrosyn, a synthetic adrenocorticotropic hormone (ACTH) used to screen patients presumed to have adrenocortical insufficiency. Cosyntropin acts similarly to purified natural ACTH, a hormone produced in the pituitary gland that stimulates the adrenal glands. The injection produces maximal secretion of 17-OH corticosteroids, 17-ketosteroids, and/or 17-ketogenic steroids.

    Cosyntropin Injection is available in 0.25-mg/vial strength in single-use vials.

  • January 15, 2013

    Pfizer announced the availability of methylphenidate extended-release oral suspension for the treatment of ADHD in patients 6 years and older. This is the first once-daily, extended-release liquid medication approved for the treatment of ADHD. It will be available in bottles of 300 mg, 600 mg, and 900 mg powder for reconstitution containing 25 mg/5 mL of methylphenidate.

    The efficacy of this agent was evaluated in a randomized, double-blind, placebo-controlled, crossover, multicenter, laboratory classroom study of children with ADHD aged 6 years to 12 years (n = 45). Use of methylphenidate extended-release oral suspension significantly improved ADHD symptoms compared with placebo at the primary endpoint of 4 hours postdose. In a secondary analysis, the agent showed significant improvement at every time point measured, from 45 minutes to 12 hours after dosing.

  • October 18, 2012

    Eli Lilly announced that pemetrexed is now approved as a maintenance therapy following first-line pemetrexed plus cisplatin therapy for locally advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC). Specifically, the agent is indicated for the maintenance treatment of patients whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. FDA approved the label inclusion of Phase III data that demonstrated progression-free and overall survival advantages in the continuation maintenance setting for these patients.

    Approval was based on results from a multicenter, double-blind Phase III trial involving 939 patients with advanced, nonsquamous NSCLC. Patients received pemetrexed 500 mg/m2 on day one of a 21-day cycle in combination with cisplatin 75 mg/m2 induction therapy. Patients whose disease had not progressed during the pemetrexed plus cisplatin induction and who had a performance status of 0–1 were randomized to receive pemetrexed maintenance (500 mg/m2 on day one of a 21-day cycle) plus best supportive care or placebo plus best supportive care until disease progression.

    Final results of the trial demonstrated a 22% reduction in the risk of death with pemetrexed compared with placebo (P = 0.02). This reduction in the risk of death resulted in an improved median overall survival from the time patients were randomized of 13.9 months for patients receiving pemetrexed, compared with 11.0 months for patients in the placebo arm. In addition, median progression-free survival measured from randomization was 4.1 months in the pemetrexed arm, compared with 2.8 months in the placebo arm.

  • April 27, 2017

    FDA announced its fifth biosimilar approval, infliximab-abda, an I.V. infusion indicated for multiple indications: treatment of Crohn disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. Infliximab-abda is a tumor necrosis factor blocker biosimilar that is similar to infliximab (Remicade—Johnson & Johnson).

    This is the second FDA approval for a biosimilar to infliximab (Remicade—Johnson & Johnson). The first was infliximab-dyyb (Inflectra—Pfizer and Celltrion). Though both infliximab-dyyb and infliximab-abda have been approved as biosimilars, they are not interchangeable.

  • July 9, 2013

    FDA has approved buprenorphine/naloxone sublingual tablets for the maintenance treatment of opioid dependence. The drug is a once-daily, sublingual tablet with higher bioavailability, a fast dissolve time, smaller tablet size, and a new menthol flavor. It should be used as part of a complete treatment plan that includes counseling and psychosocial support to prevent relapse.
     
    The sublingual tablets deliver more active ingredient to the bloodstream, allowing patients to use a lower strength, thereby reducing the amount of available drug for potential misuse and diversion. In addition, according to Orexo, the manufacturer, it is the only opioid dependence treatment option contained in the highest level of child-resistant unit dose F1 packaging, thereby reducing the chance of unintended pediatric exposure. The naloxone component also reduces the potential for I.V. misuse and diversion.
     
    Treatment should be initiated under the direction of physicians who are certified under the Drug Addiction Treatment Act of 2000 and who have been assigned a unique identification number (“X” number).
     
    Adverse events commonly observed with the sublingual administration of buprenorphine/naloxone sublingual tablets during clinical trials and postmarketing experience are headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.
     

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