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  • FDA Drug Updates

    FDA New Approvals

    23andMe Personal Genome Service Genetic Health Risk Tests

    The FDA allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These are the first direct-to-consumer tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a healthcare professional. The 23andMe GHR tests work by isolating DNA from a saliva sample, which is then tested for more than 500,000 genetic variants. Learn more about 23andMe Personal Genome Service GHR tests


    The FDA has approved Austedo (deutetrabenazine) for the treatment of chorea associated with Huntington's disease, Teva Pharm has announced. Deutetrabenazine, which had orphan drug status, is a deuterated form of the vesicular monoamine transporter 2 inhibitor tetrabenazine (Xenazine, Lundbeck Inc). Learn more about Austedo


    The FDA granted accelerated approval to Bavencio (avelumab) for the treatment of patients 12 years and older with metastatic Merkel cell carcinoma. Avelumab is a programmed death-ligand 1 blocking human IgG1 lambda monoclonal antibody. This is the first FDA-approved product to treat this type of cancer. Learn more about Bavencio


    The FDA approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Dupixent is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable. Dupixent can be used with or without topical corticosteroids. Dupixent is administered as an injection under the skin. Learn more about Dupixent


    The FDA approved Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia. This is the first drug approved by the FDA for this condition. Tardive dyskinesia is a neurological disorder characterized by repetitive, involuntary movements, usually of the jaw, lips, and tongue, such as grimacing, sticking out the tongue and smacking the lips. Some affected people also experience involuntary movement of the extremities or difficulty breathing. The FDA granted approval of Ingrezza to Neurocrine Biosciences, Inc. Learn more about Ingrezza

    Ipsogen JAK2 RGQ PCR Kit

    The FDA has granted marketing authorization for the ipsogen JAK2 RGQ PCR Kit, manufactured by Qiagen GmbH., to detect mutations affecting the Janus Tyrosine Kinase 2 (JAK2) gene. This is the first FDA-authorized test intended to help physicians in evaluating patients for suspected Polycythemia Vera (PV). Diagnoses of PV are based on clinical, biological, bone marrow histology, and cytogenetic criteria. The presence of JAK2 mutations is one of the major criteria for clinical confirmation of PV. The V617F/G1849T mutation affecting the JAK2 gene is detected in more than 94 percent of patients with PV. Learn more about the ipsogen JAK2 RGQ PCR Kit

    Juvéderm Vollure XC

    The FDA has approved Juvéderm Vollure XC for injection into facial tissue to correct moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults older than 21 years, Allergan announced. Juvéderm Vollure XC will be available in the United States in April 2017. Learn more about Juvéderm Vollure XC


    The FDA approved Kisqali (ribociclib), a cyclin-dependent kinase 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. The recommended starting dose of ribociclib is 600 mg orally (three 200 mg tablets) taken once daily with or without food for 21 consecutive days followed by 7 days off treatment. Learn more about Kisqali


    The FDA approved Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis and primary progressive multiple sclerosis (PPMS). This is the first drug approved by the FDA for PPMS. Ocrevus is an intravenous infusion given by a healthcare professional. The FDA granted approval of Ocrevus to Genentech, Inc. Learn more about Ocrevus


    Shionogi Inc. and Purdue Pharma L.P. announced that the FDA approved Symproic (naldemedine) 0.2 mg tablets C-II as a once-daily oral peripherally acting mu-opioid receptor antagonist medication for the treatment of opioid-induced constipation in adult patients with chronic non-cancer pain. Symproic is currently a Schedule II controlled substance because it is structurally related to naltrexone. Learn more about Symproic


    The FDA approved Zejula (niraparib) for the maintenance treatment (intended to delay cancer growth) of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, whose tumors have completely or partially shrunk (complete or partial response, respectively) in response to platinum-based chemotherapy. Zejula is a poly ADP-ribose polymerase inhibitor that blocks an enzyme involved in repairing damaged DNA. By blocking this enzyme, DNA inside the cancerous cells may be less likely to be repaired, leading to cell death and possibly a slow-down or stoppage of tumor growth. Learn more about Zejula

    FDA New Indications


    The FDA granted accelerated approval to Keytruda (pembrolizumab) for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or those who have relapsed after three or more prior lines of therapy. The recommended dose and schedule of pembrolizumab for cHL is 200 mg every 3 weeks for adults and 2 mg/kg (up to 200 mg) every 3 weeks for pediatric patients. Learn more about Keytruda

    Qudexy XR

    The FDA has given final approval to two supplemental new drug applications for Qudexy XR (topiramate extended-release) capsules to prevent migraine in adults and adolescents aged 12 years and older. The capsules can be taken morning or night, with or without food. They can be swallowed whole or opened and sprinkled onto soft food for easier swallowing. Qudexy XR is also approved as a monotherapy in patients 2 years of age and older with partial-onset or primary generalized tonic-clonic seizures. Additionally, it is approved as an adjunctive therapy in those in the same age category with partial-onset or primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome. Learn more about Qudexy XR

    Sovaldi and Harvoni

    The FDA approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Sovaldi were previously approved to treat HCV in adults. These are the first direct-acting antiviral treatments approved for children and adolescents with HCV. Direct-acting antiviral drugs reduce the amount of HCV in the body by preventing the virus from multiplying, and in most cases, they cure HCV. Harvoni and Sovaldi are marketed by Gilead Sciences, Inc. Learn more about Sovaldi and Harvoni

    Trokendi XR

    The FDA has granted final approval to Supernus Pharmaceuticals’ supplemental new drug applications (sNDAs) requesting a label expansion for Trokendi XR (extended-release oxcarbazepine) to include prophylaxis of migraine headache in adults and adolescents 12 years and older. Supernus was granted tentative approval of one of the two sNDAs in August 2016, with final approval subject to the pediatric exclusivity of the innovator's drug in the adolescent population, which expired March 28, 2017. Learn more about Trokendi XR

    FDA Labeling Updates


    Pfizer Inc. announced that the FDA approved a supplemental new drug application for its first-in-class cyclin dependent kinase 4/6 inhibitor, Ibrance (palbociclib), based on the results from the confirmatory Phase 3 trial PALOMA-2. The FDA action converts the accelerated approval of Ibrance to regular approval and broadens the range of anti-hormonal therapy that may be administered with Ibrance. Ibrance now is indicated in combination with an aromatase inhibitor, expanding on its earlier indication in combination with letrozole, as initial endocrine-based therapy in postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. Learn more about Ibrance


    The FDA granted regular approval to Tagrisso (osimertinib) for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor therapy. Learn more about Tagrisso

    FDA Recalls

    EpiPen and EpiPen Jr

    The FDA is alerting consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty. While the number of reported failures is small, EpiPen products that potentially contain a defective part are being recalled because of the potential for life-threatening risk if a severe allergic reaction goes untreated. Consumers should keep and use their current EpiPens if needed until they get a replacement. Consumers should contact Stericycle at 877-650-3494. Learn more about EpiPen and EpiPen Jr

    HeartStart MRx Monitor/Defibrillator

    Phillips is recalling the HeartStart MRx Monitor/Defibrillator due to electrical and battery connection issues that may prevent the device from powering up, charging, and delivering an electrical shock therapy. The device may also unexpectedly stop pacing. A delay in delivering therapy could result in serious patient injury such as permanent organ damage, brain injury, or death. The HeartStart MRx Monitor/Defibrillator is used to pace people with a slow heartbeat or to deliver lifesaving electrical shocks to people with sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating. Learn more about HeartStart MRx Monitor/Defibrillator

    Isomeric Pharmacy Solutions’ Sterile Compounded Products

    Isomeric Pharmacy Solutions (Isomeric) is voluntarily recalling all lots of sterile products compounded and packaged by Isomeric and that remain within expiry to the hospital/user level because of FDA concerns of a lack of sterility assurance. These concerns were brought to Isomeric’s attention during a recent FDA inspection. The sterile products were distributed to patients, providers, hospitals, or clinics nationwide between October 4, 2016 and February 7, 2017. Isomeric is notifying its customers of the recall by mail and telephone or email and is arranging for a return of all recalled products that remain unused. Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Providers who have dispensed any sterile product distributed by Isomeric to a patient(s) for use out of the provider’s office should contact the patient(s) to whom product was dispensed and advise the patient(s) of this recall. Learn more about Isomeric Pharmacy Solutions’ sterile compounded products

    Newport HT70 and Newport HT70 Plus Ventilators

    Medtronic is notifying customers worldwide of a voluntary field corrective action for all its Newport HT70 and Newport HT70 Plus ventilators manufactured since 2010. The voluntary field corrective action is being conducted following reports that the ventilator may reset spontaneously during normal operation, without an accompanying alarm. The reported incidence of this condition is approximately one reset in every seven million hours of ventilation. Following the reset, the ventilator enters standby mode and will not resume ventilation without intervention. In the event of the rare occurrence of a reset, healthcare professionals and/or caregivers are required to transfer the patient to another ventilator. Learn more about Newport HT70 and Newport HT70 Plus ventilators

    SynchroMed Implantable Infusion Pumps

    Medtronic is recalling the SynchroMed Implantable Infusion Pumps because a software problem may cause unintended delivery of drugs during a priming bolus procedure, used to quickly deliver a large dose of medication from the device to the patient’s spine. During this procedure, patients may receive the drug unintentionally at a high rate of infusion in the cerebrospinal fluid followed by a period of reduced drug delivery after the priming bolus. This can result in a drug overdose or under dose which can lead to serious adverse health consequences such as respiratory depression, coma, or death. The SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps (SynchroMed Implantable Infusion Pumps) are programmed to deliver prescribed drugs to a specific site inside the patient’s body. The SynchroMed pumps are used to treat primary or metastatic cancer, chronic pain, and severe spasticity. Learn more about SynchroMed Implantable Infusion Pumps

    FDA Alerts

    Breast Implant-Associated Anaplastic Large Cell Lymphoma

    The FDA has updated its understanding of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) to reflect the agency’s concurrence with the World Health Organization designation of BIA-ALCL as a rare T-cell lymphoma that can develop following breast implants. At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces. BIA-ALCL is a rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma. The exact number of cases remains difficult to determine due to significant limitations in worldwide reporting and lack of global implant sales data. Learn more about BIA-ALCL


    The FDA is warning that Viberzi (eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder. An FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death. Pancreatitis may be caused by spasm of a certain digestive system muscle in the small intestine. Healthcare professionals should not prescribe Viberzi in patients who do not have a gallbladder and should consider alternative treatment options in these patients. Hospitalizations and deaths due to pancreatitis have been reported with Viberzi use in patients who do not have a gallbladder. Symptoms of pancreatitis have occurred with just one or two doses of Viberzi at the recommended dosage for patients who do not have a gallbladder (75 mg), and who do not consume alcohol. Viberzi is a prescription medicine used to treat irritable bowel syndrome in adults when the main symptom is diarrhea (IBS-D). Learn more about Viberzi