• linkedin
  • Increase Font
  • Sharebar

    Product updates for pharmacists: 05-10-2016


    RX CARE: New drugs

    VenclextaIn April FDA approved venetoclax (Venclexta tablets; AbbVie/Genentech USA) to treat patients who have received at least one previous therapy for chronic lymphocytic leukemia with 17p deletion, as detected by the FDA-approved companion diagnostic Vysis CLL FISH probe kit. Adverse effects include tumor lysis syndrome, so a step-wise dosing schedule is required. This product received orphan drug status, breakthrough therapy designation, priority review, and accelerated approval. (www.venclexta.com) (Product image courtesy of AbbVie/Genentech USA)

    See also: New products for pharmacists 04-10-2016

    FDA has approved bromfenac ophthalmic solution 0.075% (BromSite; Sun Pharma), the first nonsteroidal anti-inflammatory drug (NSAID) approved to prevent pain and treat inflammation in the eye for patients undergoing cataract surgery. Product is scheduled to launch in the second half of 2016. (www.sunpharma.com).

    Avedro has announced FDA approval of a riboflavin ophthalmic solution (Photrexa) that treats progressive keratoconus with corneal collagen crosslinking. Keratoconus is a degenerative disease that causes progressive thinning and distortion of the cornea. The condition can result in myopia, astigmatism, and even blindness. Corneal collagen crosslinking aims to halt the progress of keratoconus by strengthening chemical bonds in the cornea. Successful crosslinking can avert the need for a corneal implant. (avedro.com)

    See also: New products for pharmacists 03-10-2016

    Bevespi AerosphereAstraZeneca has announced FDA approval of glycopyrrolate and formoterol fumarate inhalation aerosol (Bevespi Aerosphere), a twice-daily, fixed-dose dual bronchodilator indicated for the long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. The manufacturer calls it the only long-acting LAMA/LABA combination delivered through a pressurized metered-dose inhaler. This product is accompanied by a Medication Guide and a boxed warning for LABA-associated asthma-related death. (www.astrazeneca.com) (Product image courtesy of AstraZeneca)

    FDA has approved defibrotide sodium (Defitelio; Jazz Pharmaceuticals) for adults and children who develop hepatic veno-occlusive disease (VOD) with additional kidney or lung abnormalities after a stem cell transplant from blood or bone marrow. This is the first FDA-approved therapy for treatment of severe hepatic VOD, a rare and life-threatening liver condition occurring in patients who receive chemotherapy and transplant surgery. FDA granted this product orphan drug status and priority review. (https://defitelio.com)

    FDA has approved cabozantinib tablets (Cabometyx; Exelixis) to treat patients with advanced renal cell carcinoma who have received previous anti-angiogenic therapy. The manufacturer states that this product, which received fast track status and breakthrough therapy designation from FDA, is the first approved therapy shown to delay the progression of advanced kidney cancer and help extend patients’ lives. (https://cabometyx.com/) (Product image courtesy of Exelixis)

    New formulation

    Tris Pharma has announced the launch of Dyanavel XR extended-release liquid for oral suspension, approved in October 2015 to treat attention deficit/hyperactivity disorder (ADHD) in children six years of age and older. According to the manufacturer, this product is the only once-daily, extended release amphetamine-based oral liquid approved to treat ADHD in children. It is accompanied by a Medication Guide and a boxed warning that cites potential for abuse and dependence. (http://dyanavelxr.com)

    New biosimilar

    FDA has approved Celltrion’s infliximab biosimilar (Inflectra) version of Janssen Biotech’s Remicade. Inflectra is now the first and only biosimilar monoclonal antibody (mAb) therapy, and only the second biosimilar, to receive U.S. approval. Inflectra is indicated to treat patients with rheumatoid arthritis, adult ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and Crohn’s disease in adults and children. A boxed warning and a Medication Guide accompany the product, which will be marketed by Pfizer. (www.inflectra.com)

    New indication

    FDA has approved AbbVie’s Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) for use without ribavirin to treat hepatitis C patients with genotype 1b chronic hepatitis C and compensated cirrhosis. (www.viekira.com)

    Julianne Stein, Content Channel Manager
    Julianne Stein is managing editor for Drug Topics magazine.


    You must be signed in to leave a comment. Registering is fast and free!

    All comments must follow the ModernMedicine Network community rules and terms of use, and will be moderated. ModernMedicine reserves the right to use the comments we receive, in whole or in part,in any medium. See also the Terms of Use, Privacy Policy and Community FAQ.

    • No comments available