New Rx, formulation, biosimilar, indication, generics, OTC, and device/app.
In 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)
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)
AstraZeneca 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 o
ccurring 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)
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)
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)
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)
Aurobindo has seen several recent approvals, for products, including valganciclovir tablets USP, 450 mg; rivastigmine tartrate capsules USP, 1.5 mg, 3 mg, 4.5 mg, and 6 mg; esomeprazole magnesium delayed release capsules, 20 mg and 40 mg; amlodipine/valsartan tablets, 5- and 10-mg amlodipine/160-mg valsartan and 5- and 10-mg amlodipine/320-mg valsartan; oxymorphone HCl 1 mg and 5 mg; and famotidine 10 mg and 20 mg. (www.aurobindo.com)
Perfecta Products has laun
ched Zim’s Max Freeze Patches with lidocaine and menthol, in medium, large, and extra-large sizes, for temporary pain relief. (www.zimsusa.com) (Product image courtesy of Perfecta Products)
EuroPharma has launched Curamin Low Back Pain, formulated with curcumin, boswellia, white willow, devil’s claw, and the amino acid DLPA, for occasional muscle pain resulting from exercise or overuse. The manufacturer states that the combination has no dangerous effects on the kidneys, liver, or stomach and can be used by anyone. (www.EuroPharmaUSA.com) (Product image courtesy of EuroPharma)
Roche Diabetes Care has announced the integration of its Accu-Chek Connect System with the Apple HealthKit, an app for the iPhone. Accu-Chek Connect is a diabetes management system comprising the Accu-Chek Aviva Connect meter, an app (accu-chek.com/connect-ios), and an online portal enabling patients, caregivers, and healthcare providers to view, share, and access blood glucose data. Patients can use the Accu-Chek Connect app to share data with HealthKit and view it alongside other activity and health information, and physicians can use it to activate an insulin dosage calculator. (www.accu-chek.com) (Product image courtesy of Roche Diabetes Care)