Medication Monitor

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  • March 5, 2015

    FDA has expanded the approved use of nivolumab to treat patients with advanced squamous non–small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

    The most common type of lung cancer, NSCLC affects seven out of eight lung cancer patients.

    Nivolumab works by inhibiting the cellular pathway known as PD-1 protein on cells that blocks the body’s immune system from attacking cancerous cells. 

    Nivolumab’s efficacy to treat squamous NSCLC was established in a randomized trial of 272 participants, of whom 135 received nivolumab and 137 received docetaxel. The trial was designed to measure the amount of time participants lived after starting treatment (overall survival). On average, participants who received nivolumab lived 3.2 months longer than participants who received docetaxel.

    Safety and efficacy for treatment of squamous NSCLC was supported by a single-arm trial of 117 participants who had progressed after receiving a platinum-based therapy and at least one additional systemic regimen. The study was designed to measure objective response rate (ORR), or the percentage of participants who experienced partial shrinkage or complete disappearance of the tumor. Results showed 15% of participants experienced ORR, of whom 59% had response durations of 6 months or longer.   

    The most common adverse effects are fatigue, shortness of breath, musculoskeletal pain, decreased appetite, cough, nausea, and constipation. The most serious adverse effects are severe immune-mediated effects involving healthy organs, including the lung, colon, liver, kidneys, and hormone-producing glands.  

    FDA previously approved nivolumab to treat patients with unresectable or metastatic melanoma who no longer respond to other drugs.

  • May 28, 2015

    Three-month paliperidone palmitate, a long-acting atypical antipsychotic, has received FDA approval as a new indication for schizophrenia. It is the first and only schizophrenia medication to be administered four times a year, providing the longest dosing interval available.

    Before starting the medication, patients must be adequately treated with 1-month paliperidone palmitate for at least 4 months.

    In a long-term maintenance trial, 93% of patients treated with paliperidone palmitate did not experience a significant return of schizophrenia symptoms. The results of the Phase 3 study were published in March by JAMA Psychiatry. 

    Janssen anticipates that the 3-month treatment will be available by mid-June.

  • March 3, 2016

    Gilead Sciences announced FDA approval of emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF for the treatment of HIV-1 infection in patients aged 12 years and older who have no antiretroviral treatment history and HIV-1 RNA levels that are less than or equal to 100,000 copies per mL. 

    It is also indicated as replacement for a stable antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) for at least 6 months, have no history of treatment failure, and do not require substitutions associated with resistance to the individual components of the combination drug. No dosage adjustment is required in patients with estimated creatinine clearance greater than or equal to 30 mL per minute.

    The product includes a boxed warning about the risks of lactic acidosis/severe hepatomegaly with steatosis and posttreatment acute exacerbation of hepatitis B.

    Approval was supported by a bioequivalence study demonstrating that the combination therapy achieved similar drug levels of emtricitabine and TAF in the blood as elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg (E/C/F/TAF) and similar drug levels of rilpivirine as Edurant (rilpivirine 25 mg).

    Safety, efficacy, and tolerability are supported by clinical studies of rilpivirine-based therapy (administered as R+F/TDF or R/F/TDF) and F/TAF-based therapy (administered as E/C/F/TAF) in a range of patients with HIV, including treatment-naive adults and adolescents; virologically suppressed adults who switched from PI-, NNRTI-, and INSTI-based regimens; and virologically suppressed adults with mild-to-moderate renal impairment.

    The combination drug is Gilead’s second TAF-based regimen to receive FDA approval and represents the smallest tablet of any single-tablet regimen for treatment of HIV.


  • April 29, 2015

    FDA approved the first generic versions of Abilify (aripiprazole), an atypical antipsychotic for the treatment of schizophrenia and bipolar disorder. 

    Alembic Pharmaceuticals Ltd., Hetero Labs Ltd., Teva Pharmaceuticals, and Torrent Pharmaceuticals Ltd. have received FDA approval to market generic aripiprazole in multiple strengths and dosage forms.

    All atypical antipsychotics contain a Boxed Warning alerting health professionals about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis. No drug in this class is approved to treat patients with dementia-related psychosis.

    Aripiprazole’s Boxed Warning also warns about an increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. Patients should be monitored for worsening and emergence of suicidal thoughts and behaviors. Aripiprazole must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.

    In the clinical trials for Abilify, the most common adverse effects reported by adults were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness.

  • July 27, 2016

    AbbVie announced FDA approval of dasabuvir, ombitasvir, paritaprevir, and ritonavir extended-release tablets (Viekira Pak XR) for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis (Child-Pugh A). It is a once-daily, extended-release coformulation of the active ingredients in Viekira Pak.

    The combination agent is not indicated for patients with decompensated cirrhosis.

    Given once daily as three oral tablets and taken with a meal, it is used without ribavirin (RBV) in GT1b patients and in combination with twice-daily RBV in GT1a patients.

    Approval was supported by seven Phase III clinical trials in which 1,076 participants (including 181 with compensated cirrhosis) received the recommended regimen of Viekira with or without RBV for 12 weeks, or for 24 weeks in GT1a patients with compensated cirrhosis.

    A total of 95% to 100% achieved SVR12, which means HCV was not detectable in the blood 3 months after treatment ended. Cure rates varied by the HCV subtype and whether the patient had cirrhosis.