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  • FDA Drug Updates

    FDA New Approvals


    The FDA has approved Eskata, a high-concentration hydrogen peroxide topical solution, for the treatment of raised seborrheic keratosis. Eskata is scheduled to be available in the spring of 2018. Learn more about Eskata


    The FDA approved Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in adults with septic or other distributive shock. Giapreza can cause dangerous blood clots with serious consequences (clots in arteries and veins, including deep venous thrombosis); prophylactic treatment for blood clots should be used. Learn more about Giapreza


    The FDA has approved the infliximab biosimilar product Ixifi (infliximab-qbtx) for all eligible indications for the US-licensed infliximab reference product Remicade. Infliximab is a tumor necrosis factor blocker. The FDA has approved Ixifi as a treatment for patients with rheumatoid arthritis, Crohn's disease, pediatric Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. Learn more about Ixifi


    The FDA approved Luxturna (voretigene neparvovec-rzyl), a new gene therapy, to treat children and adult patients with an inherited form of vision loss that may result in blindness. Luxturna is the first directly administered gene therapy approved in the US that targets a disease caused by mutations in a specific gene. Learn more about Luxturna


    The FDA has granted marketing approval for Macrilen (macimorelin), an orally available ghrelin agonist, to be used in the diagnosis of patients with adult growth hormone deficiency. Macrilen stimulates the secretion of growth hormone from the pituitary gland into the circulatory system. Stimulated growth hormone levels are measured in four blood samples over ninety minutes after oral administration of Macrilen for the assessment of growth hormone deficiency. Learn more about Macrilen


    The FDA has provided final approval for Prexxartan (valsartan) oral solution. The FDA approval of Prexxartan makes it the first and only approved oral liquid dosage form of the angiotensin II receptor blocker valsartan in the US. Learn more about Prexxartan


    The FDA has approved the drug Rhopressa (netarsudil) ophthalmic solution 0.02%. Rhopressa helps lower elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Rhopressa is believed to reduce IOP by increasing the outflow of aqueous humor (the fluid inside the eye) through the trabecular meshwork, the main fluid drain of the eye. Learn more about Rhopressa


    The FDA has approved Siklos (hydroxyurea) to reduce the frequency of painful crises and the need for blood transfusions in pediatric patients from 2 years of age and older with sickle cell anemia with recurrent moderate to severe painful crises. This is the first FDA approval of hydroxyurea for use in pediatric patients with sickle cell disease. Learn more about Siklos

    Steglatro, Steglujan, and Segluromet

    The FDA has approved Steglatro (ertugliflozin), a sodium/glucose cotransporter 2 inhibitor as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The FDA also approved two fixed-dose combinations: Steglujan (ertugliflozin/sitagliptin), indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin is appropriate; and Segluromet (ertugliflozin/metformin), indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on a regimen containing ertugliflozin or metformin, or in patients who are already treated with both ertugliflozin and metformin. Learn more about Steglatro, Steglujan, and Segluromet


    The FDA has approved Xepi (ozenoxacin) 1% cream for the treatment of impetigo in patients 2 months of age and older. The product is applied topically twice daily for five days. Learn more about Xepi

    FDA First-Time Generic Approvals

    Butalbital and Acetaminophen 50mg/300mg Capsules

    This new generic for Phrenilin Forte is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Learn more about butalbital and acetaminophen capsules

    Doxylamine Succinate and Pyridoxine Hydrochloride 10mg/10mg Delayed-Release Tablets

    This new generic for Diclegis is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Learn more about doxylamine succinate and pyridoxine hydrochloride delayed-release tablets

    Efavirenz 50mg, 100mg, and 200mg Capsules

    This new generic for Sustiva is indicated for the treatment of HIV-1 infection. Learn more about efavirenz capsules

    Estradiol Vaginal 0.01% Cream

    This new generic for Estrace is indicated for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. Learn more about estradiol vaginal cream

    Triamcinolone Acetonide 50mg/mL, 200mg/5mL, and 400mg/10mL Injectable Suspension

    This new generic for Kenalog is indicated for use as an injectable corticosteroid therapy. Learn more about triamcinolone injectable suspension

    FDA New Dosing


    The FDA updated the product label for the cancer drug Tasigna (nilotinib) to include information for providers about how to discontinue the drug in certain patients. Tasigna, first approved by the FDA in 2007, is indicated for the treatment of patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML). Based on the updated dosing recommendations, patients with early (chronic) phase CML who have been taking Tasigna for three years or more, and whose leukemia has responded to treatment according to specific criteria as detected by a test that has received FDA marketing authorization, may be eligible to stop taking Tasigna. Learn more about Tasigna

    FDA New Indications


    The FDA granted accelerated approval to Bosulif (bosutinib) for treatment of patients with newly diagnosed chronic phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML). The FDA first approved bosutinib in 2012 for treatment of patients with chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy. Learn more about Bosulif


    The FDA approved Cabometyx (cabozantinib) for treatment of patients with advanced renal cell carcinoma (RCC). The FDA previously approved Cabometyx in 2016 for treatment of patients with advanced RCC who have received prior anti-angiogenic therapy. The approval provides for treatment in the first-line setting. Learn more about Cabometyx

    Fluarix Quadrivalent

    The FDA approved an expanded indication for Fluarix Quadrivalent (influenza vaccine) to include use in persons 6 months and older. Prior to this, the vaccine was only approved for active immunization against influenza A subtype viruses and type B viruses, in persons 3 years of age and older. Learn more about Fluarix Quadrivalent


    The FDA expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast cancer, and it is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a “BRCA” gene mutation. Learn more about Lynparza


    The FDA approved Opdivo (nivolumab), an anti-PD1 monoclonal antibody, for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection. Opdivo was previously approved for the treatment of patients with unresectable or metastatic melanoma. Learn more about Opdivo


    The FDA approved Perjeta (pertuzumab) for use in combination with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. Learn more about Perjeta


    Expansion of the indication for Procysbi (cysteamine bitartrate) delayed-release capsules has been granted to include children one year of age and older living with nephropathic cystinosis. With this update to the indication, the Procysbi prescribing information now includes revised guidance for physicians administering the medicine to pediatric patients, including new clinical evidence and dosing information for very young children. Procysbi was previously FDA-approved for adults and children as young as two years of age. Learn more about Procysbi


    The FDA has approved the use of Trisenox (arsenic trioxide) injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. Learn more about Trisenox

    Xeljanz/Xeljanz XR

    The FDA has approved Xeljanz/Xeljanz XR (tofacitinib) for treatment of adults with active psoriatic arthritis who have failed to respond adequately or are intolerant to methotrexate or other disease-modifying antirheumatic drugs. Xeljanz/Xeljanz XR is a selective oral Janus kinase inhibitor that interrupts signaling of several cytokines involved in immune response. It was first approved by the FDA in 2012 for adults with moderately to severely active rheumatoid arthritis who have not responded adequately to, or are intolerant of, methotrexate. Learn more about Xeljanz/Xeljanz XR


    The FDA has approved the supplemental Biologics License Application for Xgeva (denosumab) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma. Learn more about Xgeva

    FDA Recalls

    AuroMedics Pharma LLC Ampicillin and Sulbactam for Injection

    AuroMedics Pharma LLC is voluntarily recalling lot AF0117001-A, Expiry date Dec 2018, of ampicillin and sulbactam for injection USP, 1.5g (equivalent to 1g ampicillin as the sodium salt plus 0.5g sulbactam as the sodium salt) in a single-dose vial, to the hospital level. The product has been found to contain glass particles. Learn more about the ampicillin and sulbactam for injection recall

    AuroMedics Pharma LLC Linezolid Injection

    AuroMedics Pharma LLC is voluntarily recalling one lot of linezolid injection 600mg/300mL flexible bags, NDC 55150 -242 -51 batch CLZ160007 expiration August 2018 to the hospital level. This batch was distributed May 15 through August 14, 2017. The product was found to contain white particulate matter that has been identified as mold. This problem was discovered as a result of a product complaint in which the contents of one flexible bag from one batch CLZ160007 was found to contain white particulate matter. Learn more about the linezolid injection recall

    AuroMedics Pharma LLC Pantoprazole Sodium for Injection

    AuroMedics Pharma LLC is voluntarily recalling one lot of pantoprazole sodium for injection 40mg per vial, to the hospital level. The product was found to contain glass particles in the vial. This problem was discovered as a result of a product complaint in which the contents of one vial from one batch was found to contain a piece of glass. Learn more about the pantoprazole sodium for injection recall

    International Laboratories, LLC Clopidogrel Tablets

    International Laboratories, LLC is voluntarily recalling Lot# 117099A of clopidogrel 75mg tablets, packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as clopidogrel tablets USP 75mg but may contain clopidogrel 75mg or simvastatin tablets USP 10mg. Learn more about the clopidogrel tablet recall

    Marmex Corp Blue Pearl All Natural Male Enhancement Supplement

    Marmex Corp is voluntarily recalling All lots of Blue Pearl All Natural Male Enhancement Supplement, 500mg, to the consumer level. FDA analysis has found the products to contain sildenafil. Learn more about the Blue Pearl All Natural Male Enhancement Supplement recall

    PharMEDium Services, LLC Sterile Products

    PharMEDium Services, LLC is voluntarily recalling lots of multiple injectable drug products including fentanyl citrate, morphine sulfate, hydromorphone hydrochloride (HCl), midazolam HCl, succinylcholine chloride, bupivacaine HCl, ropivacaine HCl, labetalol HCl, adenosine, and ephedrine sulfate to the hospital/user level, due to a lack of assurance of sterility. To date, PharMEDium has not received any reports of complaints related to the products but is issuing this recall out of an abundance of caution following a commitment made during a recent inspection of the company’s facility. Learn more about the PharMEDium Services, LLC sterile products recall

    FDA Alerts

    Gadolinium-Based Contrast Agents (GBCAs) Warning

    The FDA is requiring a new class warning and other safety measures for all GBCAs for magnetic resonance imaging concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs. Gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function, and the FDA has concluded that the benefit of all approved GBCAs continues to outweigh any potential risks. Learn more about the GBCAs warning

    Legal Lean Syrup and Coco Loko Warning

    The FDA posted a warning letter to the marketers and distributors of Legal Lean Syrup, a drink, and Coco Loko, a “snortable” chocolate powder, for selling unapproved new drugs and misbranded drugs and promoting them as alternatives to street drugs. The FDA requested that Arco Globus Trading LLC (dba Arco Globus International), Legal Lean LLC and LegalLeanStore.com respond to the FDA within 15 working days and include a statement of how the issues noted in the warning letter will be corrected. Learn more about the Legal Lean Syrup and Coco Loko Warning

    Long-Acting Beta agonists (LABAs) and Inhaled Corticosteroids (ICS) Boxed Warning Removal

    The FDA's most prominent warning, the Boxed Warning, about asthma-related death has been removed from the drug labels of medicines that contain both an ICS and LABA. An FDA review of four large clinical safety trials shows that treating asthma with LABAs in combination with ICS does not result in significantly more serious asthma-related side effects than treatment with ICS alone. A description of the four trials is now also included in the Warnings and Precautions section of the drug labels. These trials showed that LABAs, when used with ICS, did not significantly increase the risk of asthma-related hospitalizations, the need to insert a breathing tube known as intubation, or asthma-related deaths, compared to ICS alone. Learn more about the LABAs and ICS boxed warning removal

    New Website for Managing Antibiotic Therapy

    The FDA announced a new approach for obtaining critical updates regarding antibiotics and antifungal drugs to healthcare professionals as part of an overall effort to combat antimicrobial resistance. The agency created a website that will provide direct and timely access to information about when bacterial or fungal infections are likely to respond to a specific drug. This approach is intended to aid healthcare professionals in making more informed prescribing decisions that will both benefit their patients and prevent the spread of resistant bacteria. Learn more about the new website for managing antibiotic therapy

    Over-the-Counter (OTC) Antiseptic Products Ban

    The FDA has finalized a rule that bans the marketing of OTC healthcare antiseptic products containing triclosan or any of 23 other active ingredients. The FDA found that these ingredients are not generally recognized as safe and effective, since the companies that manufacture them have failed to provide additional safety and efficacy data. Learn more about OTC antiseptic products ban

    Risk-Based Enforcement Approach for Homeopathic Drugs

    The FDA proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. This proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices. Learn more about risk-based enforcement approach for homeopathic drugs