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  • FDA Drug Updates

    FDA New Approvals


    Endo International plc has announced that its operating company, Endo Pharmaceuticals Inc., has received FDA approval of Aveed (testosterone undecanoate) injection for the treatment of adult men with hypogonadism (commonly known as Low-T) that is associated with a deficiency or absence of the male hormone testosterone. Aveed is a new prescription medicine indicated to produce serum testosterone levels in the normal range by administration of a single 3mL (750mg) intramuscular injection given once at initiation of therapy, at 4 weeks, and then every 10 weeks thereafter. It is expected to be available in early March.
    For more information, visit: www.endo.com/news-events

    G4 Platinum (Pediatric) System

    The FDA has approved the expanded use of the Dexcom G4 Platinum Continuous Monitoring System for patients with diabetes who are ages 2 to 17 years. The G4 Platinum System, which monitors blood glucose levels in people with diabetes, had been approved for patients ages 18 and older. The G4 Platinum System is an externally worn system that continuously displays an estimate of blood glucose levels and the direction and rate of change of these estimates. The device is intended to be worn by a single patient for up to seven days. It requires a prescription and is meant to complement, not replace, information obtained from standard home glucose monitoring devices. The previously approved G4 Platinum System is for insertion of the sensor in the abdomen only. The new G4 Platinum (Pediatric) System includes the upper buttock in addition to the abdomen as sensor insertion sites. The device system components (sensor and transmitter) are unmodified from the previous system. The G4 Platinum (Pediatric) System is manufactured by Dexcom, Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm384495.htm


    Anika Therapeutics, Inc. has announced that it has received marketing approval for Monovisc from the FDA. Monovisc is a single injection supplement to synovial fluid of the osteoarthritic joint, used to treat pain and improve joint mobility in patients suffering from osteoarthritis of the knee. Monovisc is the first FDA-approved single injection product with hyaluronic acid from a non-animal source. It is comprised of a sterile, clear, biocompatible, resorbable, viscoelastic fluid composed of partially cross-linked sodium hyaluronate in phosphate buffered saline. Monovisc will be marketed in the US by DePuy Synthes, Mitek Sports Medicine (Mitek).
    For more information, visit: ir.anikatherapeutics.com/releasedetail.cfm?ReleaseID=828235


    The FDA has approved Myalept (metreleptin for injection) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy. Myalept is available only through the Myalept Risk Evaluation and Mitigation Strategy (REMS) Program. Under this REMS program, prescribers must be certified with the program by enrolling in and completing training. Pharmacies must be certified with the program and may only dispense Myalept after receiving a Myalept REMS Prescription Authorization Form for each new prescription. Myalept is also approved with a Medication Guide and instructions for use that provides patients with important information about the medication. The guide will be distributed each time a patient fills a prescription. The FDA is requiring seven studies (postmarketing requirements) for Myalept, including a long-term prospective observational study (product exposure registry) of patients treated with Myalept, a study to assess for the immunogenicity (antibody formation) of Myalept, and an assessment and analysis of spontaneous reports of potential serious risks related to the use of Myalept. Eight additional studies are being requested as postmarketing commitments. Myalept is marketed by Amylin Pharmaceuticals, LLC.
    For more information, visit: www.fda.gov/newsevents/newsroom/pressannouncements/ucm387060.htm


    The FDA has approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension. The FDA is approving Northera under the accelerated approval program, which allows for approval of a drug to treat a serious disease based on clinical data showing that the drug has an effect on an intermediate clinical measure (in this case, short-term relief of dizziness) that is reasonably likely to predict the outcome of ultimate interest (relief of dizziness during chronic treatment). Northera has a boxed warning to alert healthcare professionals and patients about the risk of increased blood pressure while lying down (supine hypertension). Northera received orphan-product designation from the FDA because it is intended to treat a rare disease or condition. Northera is made by Chelsea Therapeutics Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm386311.htm

    PillCam COLON

    Given Imaging Ltd has announced that the FDA has cleared PillCam COLON as a new modality to provide visualization of the colon. It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation and a complete evaluation of the colon was not technically possible. PillCam COLON received clearance under the direct de novo classification for devices with low to moderate risk that have no predicate on the market.
    For more information, visit: www.givenimaging.com/en-us/Innovative-Solutions/Capsule-Endoscopy/pillcam-colon/Pages/COLON-Press-release.aspx


    Iroko Pharmaceuticals, LLC has announced that the FDA has approved Tivorbex (indomethacin) capsules, a nonsteroidal anti-inflammatory drug, at 20mg and 40mg doses for the treatment of mild to moderate acute pain in adults. Tivorbex was approved at dosage strengths that are 20% lower than the 25mg and 50mg indomethacin products currently on the market.
    For more information, visit: www.iroko.com/news/press-releases/


    BioMarin Pharmaceutical Inc. has announced that the FDA has approved Vimizim (elosulfase alfa) for patients with mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome). Vimizim is an enzyme replacement treatment for Morquio A syndrome. Shipments of Vimizim to the distribution channels will commence immediately, and BioMarin will begin promotion of Vimizim in the US immediately.
    For more information, visit: investors.bmrn.com/releasedetail.cfm?ReleaseID=825970

    FDA New Indications


    The FDA has expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia patients who have received at least one previous therapy. In November 2013, the FDA granted Imbruvica accelerated approval to treat patients with mantle cell lymphoma, a rare and aggressive type of blood cancer, if those patients received at least one prior therapy. Imbruvica is manufactured by Pharmacyclics.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm385764.htm


    Vertex Pharmaceuticals Incorporated has announced that the FDA has approved a supplemental New Drug Application (sNDA) for Kalydeco (ivacaftor) for people with cystic fibrosis (CF) who are ages 6 and older who have one of eight additional mutations in the CF transmembrane conductance regulator gene. Kalydeco was first approved in January 2012 for people with CF who are ages 6 and older and have at least one copy of the G551D mutation. With the approval of the sNDA, Kalydeco is now approved for use in people with CF with the following nine mutations: G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, and G1349D.
    For more information, visit: investors.vrtx.com/releasedetail.cfm?ReleaseID=827435


    The FDA approved Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with advanced melanoma that is unresectable or metastatic. In May 2013, the FDA approved both drugs as single agents to treat patients with unresectable or metastatic melanoma. Mekinist and Tafinlar are marketed by GlaxoSmithKline.
    For more information visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm381159.htm

    FDA New Formulation

    Bydureon Pen

    AstraZeneca has announced that the FDA has approved the Bydureon Pen (exenatide extended-release for injectable suspension) 2mg as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The Bydureon Pen is a prefilled, single-use pen injector, eliminating the need for the patient to transfer the medication between a vial and syringe during the self-injection process. The Bydureon Pen contains the same formulation and dose as the original Bydureon single-dose tray, providing the same continuous release of exenatide. AstraZeneca plans to make the Bydureon Pen available for patients in the US later this year. The Bydureon single-dose tray will remain on the market in the US for patients prescribed Bydureon.
    For more information, visit: www.astrazeneca.com/Media/Press-releases/Article/03032014-us-fda-approves-bydureon-pen

    FDA First-Time Generic Approval


    Teva Pharmaceutical Industries Ltd. has announced the approval of the generic equivalent to Evista (raloxifene) tablets, 60mg, in the US. Teva was first to file, making the product eligible for 180 days of marketing exclusivity. Teva will begin shipping the product within the next 30 days.
    For more information, visit: news.tevausa.com/phoenix.zhtml?c=251945&p=irol-newsArticle&ID=1905868&highlight=

    FDA Recalls

    Acetylcysteine Solution 10%

    Ben Venue Laboratories notified health professionals and their medical care organizations of a nationwide product recall of Acetylcysteine Solution 10%, manufactured for Roxane Laboratories, NDC #0054-3025-02 – Lot 2005479 – Exp. Date March 2014. The recall was initiated on February 14, 2014 after the discovery of a single visible glass particle in a vial within the lot listed above. The nationwide voluntary recall is to the patient level. This recall is limited to lot number 2005479.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm386133.htm

    ACME Monaco Guidewire .035x150 3MMJ TCFC, Item 88241

    An ACME Monaco Guidewire .035x150 3MMJ TCFC, item number 88241, is designed to fit inside a percutaneous catheter for directing the catheter through a blood vessel. This guidewire is used in various surgical convenience kits assembled and marketed by Medline Industries, Inc. Various convenience kits containing ACME Monaco Guidewire .035x150 3 MMJ TCFC, item number 88241, have a potential for the coating to flake off of the wire. Use of this recalled product may result in serious adverse health consequences. The affected products were distributed from March 2013 through August 2013.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm387123.htm

    Dianeal PD-2 Peritoneal Dialysis Solution

    Baxter International Inc. has announced that it has initiated a voluntary recall in the US of a single lot of Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose 6000mL (Ambu-Flex II) to the hospital/user level. The recall is being initiated because of complaints of particulate matter, identified as mold, resulting from a leak in the container. The one affected lot is C903799, expiration 05/15 (product code L5B9710), NDC 00941-0411-11. Product affected by this recall was packaged in flexible plastic containers and distributed to dialysis centers, facilities, distributors, and patients in the US. The affected lot was distributed to customers between May 2013 and January 2014. Unaffected lot numbers can continue to be used according to the instructions for use.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm388139.htm

    Effexor XR 150mg Extended-Release Capsules and Greenstone’s Venlafaxine HCl 150mg Extended-Release Capsules

    Pfizer Inc. is voluntarily recalling one lot of 30-count Effexor XR (venlafaxine HCl) 150mg extended-release capsules, one lot of 90-count Effexor XR (venlafaxine HCl) 150mg extended-release capsules, and one lot of 90-count Greenstone LLC-branded Venlafaxine HCl 150mg extended-release capsules. This action is being taken because of a pharmacist report that one bottle of Pfizer’s Effexor XR contained one capsule of Tikosyn (dofetilide) 0.25mg in addition to the Effexor XR capsules. Although Pfizer has not received any other such reports, these three lots are being voluntarily recalled as a precaution because they were packaged on the same line. While there is a very low probability that other bottles of Effexor XR contain a Tikosyn capsule, Pfizer has initiated this voluntary recall as a precaution. This recall is to the patient level and involves Pfizer lot numbers V130142 and V130140, which both expire in October 2015, and Greenstone lot number V130014, which expires in August 2015. These products were distributed nationally to wholesalers, distributors, certain government agencies, patient assistance programs, and retailers, such as pharmacies and hospitals.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm388329.htm

    Etomidate Injection

    Mylan Inc. has announced that its subsidiary, Agila Specialties Private Limited, is conducting a voluntary nationwide recall to the hospital/user level of 10 lots of Etomidate Injection 2mg/mL – 10mL and 20mL. The 10 lots were manufactured by Polska sp.zo.o in Warsaw, Poland. All of the products bear a Pfizer label. Agila Specialties Private Limited initiated the recall on February 13, 2014, due to the potential for small, black particles, identified as paper shipper labels, to be present in individual vials; the potential for missing lot number and/or expiry date on the outer carton; and the potential for illegible/missing lot number and expiry on individual vials. Mylan and Pfizer have not received any reports of adverse events related to the recalled product to date. The product was distributed nationwide to distributors, retailers, hospitals, pharmacies, and/or clinics. Mylan notified its customers of the recall by letter on February 13, 2014.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm386547.htm


    The FDA is notifying healthcare professionals, patients, and caregivers of adverse events reported in patients who were administered L-citrulline repackaged and distributed by Medisca Inc. L-citrulline is used to treat certain urea cycle disorders, rare genetic disorders primarily diagnosed in children. The FDA has received adverse event reports associated with potentially subpotent L-citrulline. The FDA has tested samples from recalled lots of Medisca’s L-citrulline product. The samples were analyzed by several laboratory methods to identify the ingredient that was repackaged by Medisca and labeled as L-citrulline. The FDA has found that the samples contain N-acetyl-leucine, which is used to treat a certain type of dizziness (acute vestibular vertigo). No L-citrulline was found in the samples the FDA tested. Testing by Medisca indicated that L-citrulline, lot numbers 95482/A, 95482/B, 95482/C, 95482/D and 96453/A, 96453/B, 96453/C, 96453/D do not contain L-citrulline.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm385978.htm

    Philips Respironics Trilogy Ventilators

    Respironics, Inc. has announced a worldwide recall of approximately 600 Philips Respironics Trilogy Ventilators, comprising Trilogy Ventilator Models 100, 200, and 202. On February 11, 2014, Philips Respironics initiated a voluntary recall to address a potentially defective component on the Trilogy Ventilator power management board, which could affect the function of the device. If this issue is not corrected, it is possible that the ventilator may fail to deliver mechanical breaths and that the alarm functionality may be reduced to indicate ventilatory failure, resulting in serious adverse health consequences or death. There have been no reports of death or serious injury related to this potential problem. During production testing, Philips Respironics discovered that the Trilogy ventilators contain a potentially defective ferrite component on the power management board of the device. This recall affects 600 Trilogy Ventilator devices shipped between December 31, 2013, and January 30, 2014. Philips Respironics is instructing customers to remove affected devices from service and to return them to Philips for replacement. Philips Respironics has notified all US and international distributors, providers, and customers that may have devices subject to this recall, and has provided affected device serial numbers for identification.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm386490.htm

    Teleflex Medical, ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port

    The FDA has notified healthcare professionals of a Class I Recall of the Teleflex Medical, ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port. The affected tracheal tube may kink during patient use. The affected products were manufactured from December 2009 through November 2013 and distributed from March 2010 through December 2013.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm387041.htm

    FDA Alerts


    The FDA has concluded that Doribax (doripenem), an antibacterial drug that has been used to treat patients who develop pneumonia while on ventilators, carries an increased risk of death and lower clinical cure rates compared to use of imipenem and cilastatin for injection (marketed in the US under the name Primaxin). Based on the FDA’s analysis of data from a three-year clinical trial that was prematurely stopped in 2011 due to these safety concerns, the FDA has approved changes to the Doribax drug label that describe these risks. Doribax is not approved to treat any type of pneumonia, and the revised label also includes a new warning about this unapproved use. Doribax is still considered safe and effective for its FDA-approved indications - treatment of adults with complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis.
    For more information, visit: www.fda.gov/Drugs/DrugSafety/ucm387971.htm

    HeartMate II LVAS Pocket System Controller

    Thoratec Corporation initiated a voluntary worldwide Medical Device Correction in order to update its labeling and training materials for the HeartMate II LVAS Pocket System Controller (the “Pocket Controller”). This safety advisory is being issued because some patients and caregivers have experienced difficulties with the process of changing from a primary system controller to their backup system controller. These difficulties have resulted in four deaths and five reports of loss of consciousness or other symptoms of hypoperfusion. Thoratec’s investigations of these reports have not revealed any failures of the devices to meet specifications or deficiencies in quality control procedures. No product needs to be returned to Thoratec. Physicians who prescribe the HeartMate II LVAS Pocket Controller should immediately review the updated labeling and training materials provided in the Urgent Medical Device Correction Letter with all clinical personnel responsible for training patients and caregivers on the use of the Pocket System Controller. All patients using the Pocket Controller and their caregivers should be retrained on the use of the device and be provided with updated Patient Handbook information. The Urgent Medical Device Correction Letter applies to all HeartMate II LVAS Pocket Controllers manufactured and distributed to date in the US and worldwide.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm387994.htm