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  • FDA Drug Updates

    FDA New Approvals


    The FDA has approved Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. Flublok contains three, full-length, recombinant hemagglutinin (HA) proteins to help protect against two influenza virus A strains, H1N1 and H3N2, and one influenza virus B strain. Flublok is approved for the prevention of seasonal influenza in people 18 through 49 years of age. Unlike current flu vaccines, Flublok does not use the influenza virus or eggs in its production. Flublok’s novel manufacturing technology allows for production of large quantities of the influenza virus protein, HA, the active ingredient in all inactivated influenza vaccines that is essential for entry of the virus into cells in the body. The majority of antibodies that prevent influenza virus infection are directed against HA. While the technology is new to flu vaccine production, it is used to make vaccines that have been approved by the FDA to prevent other infectious diseases. Flublok is manufactured by Protein Sciences Corp, of Meriden, Conn.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm335891.htm?source=govdelivery

    Kazano, Nesina, Oseni

    The FDA has approved three new related products for use with diet and exercise to improve blood sugar control in adults with type 2 diabetes: Nesina (alogliptin) tablets, Kazano (alogliptin and metformin hydrochloride) tablets, and Oseni (alogliptin and pioglitazone) tablets. Alogliptin is a new active ingredient, while metformin hydrochloride and pioglitazone are already FDA-approved for the management of type 2 diabetes. The FDA is requiring five postmarketing studies for Nesina: a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for liver abnormalities, serious cases of pancreatitis, and severe hypersensitivity reactions; and three pediatric studies under the Pediatric Research Equity Act (PREA), including a dose finding study and two safety and efficacy studies, one with Nesina as a monotherapy and one with Nesina and metformin. Also, the FDA is requiring two postmarketing studies for Kazano: an enhanced pharmacovigilance program to monitor for liver abnormalities, serious cases of pancreatitis, and severe hypersensitivity reactions; and a pediatric safety and efficacy study under the PREA. Kazano carries a Boxed Warning for lactic acidosis, a build-up of lactic acid in the bloodstream, associated with metformin use. In addition, the FDA is requiring an enhanced pharmacovigilance program for Oseni to monitor for liver abnormalities, serious cases of pancreatitis, and severe hypersensitivity reactions. Oseni carries a Boxed Warning for heart failure associated with pioglitazone use. Nesina, Kazano, and Oseni are distributed by Takeda Pharmaceuticals America, Inc., Deerfield, Ill.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm336942.htm


    The FDA has approved Kynamro (mipomersen sodium) injection as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemia (HoFH). The addition of Kynamro helps to reduce low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B, total cholesterol, and non-high density lipoprotein-cholesterol (non HDL-C). Kynamro carries a Boxed Warning on the serious risk of liver toxicity because it is associated with liver enzyme abnormalities and accumulation of fat in the liver, which could lead to progressive liver disease with chronic use. The FDA has approved Kynamro with a Risk Evaluation and Mitigation Strategy (REMS) with elements to ensure safe use, including prescriber and pharmacy certification, and documentation of safe-use conditions, which requires a prescription authorization form for each new prescription. The most common adverse reactions in the clinical trial included injection-site reactions, flu-like symptoms, nausea, headache, and elevations in liver enzymes. The FDA is requiring four postmarketing studies for Kynamro: the development of a sensitive assay that binds double-stranded (ds) DNA; a study to assess for the presence of antibodies to ds-DNA in patients treated with Kynamro; a long-term registry of patients with HoFH to determine the long-term safety of Kynamro; and an enhanced pharmacovigilance program to monitor reports of malignancy, immune-mediated reactions, and hepatic abnormalities in patients treated with Kynamro. Kynamro is manufactured by Genzyme Corp., based in Cambridge, Mass.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm337195.htm


    The FDA has approved Octaplas, a pooled plasma (human) blood product for the replacement of clotting proteins (coagulation factors) in certain medical conditions where patients have insufficient levels. Octaplas is a sterile, frozen solution of pooled human plasma from several donors that has been treated with a solvent detergent process. This process kills certain viruses and thereby minimizes the risk of serious virus transmission. The plasma used to manufacture Octaplas is collected from U.S. donors who have been screened and tested for diseases transmitted by blood, and are determined to be suitable donors.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm336009.htm?source=govdelivery


    The FDA has approved Oxytrol for Women, the first over-the-counter treatment for overactive bladder in women ages 18 years and older. Oxytrol will remain available for men with overactive bladder by prescription only. Oxytrol for Women contains oxybutynin, a medicine that helps relax the bladder muscle. Oxytrol for Women is a patch that is applied to the skin every four days. The patch delivers 3.9 milligrams of oxybutynin per day. Oxytrol for Women is marketed by Merck, based in Whitehouse Station, N.J.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm336815.htm?source=govdelivery

    Rebif Rebidose

    EMD Serono, Inc., a subsidiary of Merck KgaA and Pfizer Inc., has announced that the FDA has approved Rebif Rebidose (interferon beta-1a), a single-use auto-injector for the self-administration of Rebif. Rebif Rebidose was designed with the objective to assist with ease of use and to offer patients an alternative delivery option. Rebif Rebidose will be available in a monthly pack in two different doses, 22 micrograms and 44 micrograms, and in a titration pack. Rebif Rebidose will be available in the U.S. in early 2013.
    For more information, visit: press.pfizer.com/press-release/emd-serono-and-pfizer-announce-fda-approval-rebif-rebidose-interferon-beta-1a


    Bayer HealthCare Pharmaceuticals Inc. has announced that the FDA has approved Skyla (levonorgestrel-releasing intrauterine system) 13.5 mg, a new hormone-releasing system that is placed in the uterus for the prevention of pregnancy for up to three years. Skyla is a small, flexible plastic T-shaped device containing 13.5 mg of levonorgestrel. Women can have Skyla placed by a healthcare provider during an in-office visit. Skyla is intended for long-term use for up to three years but may be removed by a healthcare provider at any time. Women could become pregnant as soon as Skyla is removed, so they should use another method of birth control if they do not want to become pregnant. Skyla became available by prescription the week of February 11.
    For more information, visit: pharma.bayer.com/html/pdf/FINAL-Skyla-approval-release.pdf


    Santarus, Inc. has announced that the FDA has approved Uceris (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis. Uceris contains budesonide, in a novel oral tablet formulation that utilizes proprietary MMX® multi-matrix system colonic delivery technology. The approved dosing regimen for adult patients is one 9-mg tablet taken orally once daily in the morning for up to 8 weeks. Uceris was developed in collaboration with Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals S.p.A. The company expects to commence the commercial launch of Uceris in March 2013.
    For more information, visit: ir.santarus.com/releasedetail.cfm?ReleaseID=733438

    Xience Xpedition Everolimus Eluting Coronary Stent System

    Abbott has announced that the Xience Xpedition Everolimus Eluting Coronary Stent System received FDA approval and is launching immediately in the U.S. Xience Xpedition features a new stent delivery system designed to optimize deliverability, particularly in challenging coronary anatomies. Xience Xpedition will be available in the largest size matrix in the U.S. market, with both rapid exchange and over-the-wire configurations. Xience Xpedition has diameters ranging from 2.25 mm to 4 mm, including a 3.25 mm diameter, and lengths from 8 mm to 38 mm.
    For more information, visit: www.abbott.com/press-release/abbott-announces-fda-approval-and-us-launch-of-nextgeneration-xience-xpedition-drug-eluting-sten.htm


    NuPathe Inc. has announced that the FDA has approved Zecuity (sumatriptan iontophoretic transdermal system) for the acute treatment of migraine, with or without aura, in adults. Zecuity is a single-use, battery-powered patch that actively delivers sumatriptan, through the skin. Throughout the four-hour dosing period, the microprocessor within Zecuity continuously monitors skin resistance and adjusts drug delivery accordingly to ensure delivery of 6.5 mg of sumatriptan. Zecuity provides relief of both migraine headache pain and migraine-related nausea. The most common side effects of Zecuity are application-site pain, tingling, itching, warmth, and discomfort.
    For more information, visit: ir.nupathe.com/press-releases/nupathe-s-zecuity-approved-by-the-fda-for-the-acut-nasdaq-path-975802

    FDA New Indications


    Genentech, a member of the Roche Group, has announced that the FDA has approved a new use of Avastin (bevacizumab) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for people with metastatic colorectal cancer (mCRC). The new indication will allow people who received Avastin plus an irinotecan or oxaliplatin-containing chemotherapy as an initial treatment (first-line) for mCRC to continue to receive Avastin plus a different irinotecan or oxaliplatin-containing chemotherapy after their cancer worsens (second-line treatment). Avastin is the only biologic medicine approved by the FDA to treat people with mCRC in combination with intravenous 5FU-based chemotherapy as an initial treatment, as treatment for people whose cancer worsened after chemotherapy alone, and now as a treatment for people whose cancer has worsened after initial treatment with an Avastin-based regimen.
    For more information, visit: www.gene.com/media/press-releases/14307/2013-01-23/fda-approves-new-use-of-avastin-plus-che/


    Allergan, Inc. has announced that the FDA has approved Botox (onabotulinumtoxinA) for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency in adults who have had an inadequate response to or are intolerant of an anticholinergic medication.
    For more information, visit: agn.client.shareholder.com/releasedetail.cfm?ReleaseID=734524


    The FDA has expanded the approved use of Exjade (deferasirox) to treat patients ages 10 years and older who have chronic iron overload resulting from a genetic blood disorder called non-transfusion-dependent thalassemia (NTDT). The FDA is also authorizing marketing of FerriScan as an imaging companion diagnostic for Exjade therapy in patients with NTDT. The agency previously cleared FerriScan for measuring liver iron concentration (LIC), but its use in Exjade clinical studies to select patients for therapy, and to manage therapy, defined its role as an imaging companion diagnostic necessary for Exjade’s safe and effective use. FerriScan measures LIC non-invasively using magnetic resonance imaging. Exjade was previously approved for treatment of chronic iron overload due to blood transfusions in patients ages 2 years and older, and this approval extends its use to treat patients with NTDT who show iron overload. Exjade should be used in patients with NTDT who have an LIC of at least 5 milligrams of iron per gram of dry liver tissue weight. Exjade’s new indication is being approved under the FDA’s accelerated approval program, which provides patients earlier access to promising new drugs intended to treat serious or life-threatening illnesses while the company conducts additional studies to confirm the drug’s clinical benefit. Exjade is marketed by Novartis, based in East Hanover, N.J. FerriScan is marketed by Resonance Health, based in Australia.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm336478.htm


    The FDA has approved a new use of Gleevec (imatinib) to treat children newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). Gleevec, a tyrosine kinase inhibitor, blocks the proteins that promote the development of cancerous cells. It should be used in combination with chemotherapy to treat children with Ph+ ALL. The most common side effects observed in children with Ph+ ALL treated with Gleevec in combination with chemotherapy included: decreased levels of infection-fighting blood cells called neutrophils; decreased levels of blood platelets, which assist in blood clotting; liver toxicity; and infection. Gleevec is marketed by Novartis, based in East Hanover, N.J.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm336868.htm


    Sobi has announced that the FDA has approved Kineret (anakinra) for the treatment of children and adults with neonatal-onset multisystem inflammatory disease (NOMID). Kineret is the first and only FDA-approved therapy for NOMID. This is the first approval allowing the use of Kineret in children. Kineret was approved for NOMID under an Orphan Drug designation. A priority review was granted by the FDA based on the product's potential to provide a significant advance in therapy for the NOMID patient population where no adequate therapy exists. Sobi will provide a prefilled syringe with a graduated label to allow flexible dosing in children.
    For more information, visit: www.sobi.com/en/Investors--Media/News/RSS/?RSS=http://cws.huginonline.com/S/134557/PR/201301/1668782.xml

    Prevnar 13

    Pfizer Inc. has announced that the FDA has granted approval for the expansion of the company’s pneumococcal conjugate vaccine, Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), for use in older children and adolescents ages 6 years through 17 years for active immunization for the prevention of invasive disease caused by the 13 Streptococcus pneumoniae serotypes contained in the vaccine. For this age group, Prevnar 13 is administered as a one-time dose to patients who have never received Prevnar 13.
    For more information, visit: press.pfizer.com/press-release/pfizer-receives-fda-approval-use-prevnar-13-vaccine-naive-children-and-adolescents-age

    FDA Recalls

    Bausch and Lomb 27G Sterile Cannula Packed in Amvisc and Amvisc Plus Ophthalmic Viscosurgical Devices

    Bausch and Lomb notified healthcare professionals of a Class I recall of certain Bausch and Lomb 27G Sterile Cannula Packed in Bausch and Lomb Amvisc 1.2 percent Sodium Hyaluronate (Model 59051, 59081, 59051L, 59081L) and Amvisc Plus 1.6 percent Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L) Ophthalmic Viscosurgical Device. The cannulas may leak viscoelastic material or detach from the syringe during injection. In rare incidences, detachment has resulted in serious patient injury. Bausch and Lomb advised customers to discontinue the use and either destroy or quarantine the product under refrigeration pending a Sales Representative visit to your site.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm336466.htm?source=govdelivery

    Ferrous Sulfate Tablets

    Advance Pharmaceutical Inc. has announced that it is conducting a voluntary nationwide recall of one lot of Ferrous Sulfate Tablets, 325 mg, Lot 12G468 Exp. 07/14, UPC Barcode 0 0536-5890-01 3. The lot was manufactured and packaged in 100 count bottles by Advance Pharmaceutical Inc. under the label of Rugby Natural Iron Supplement Ferrous Sulfate. Advance Pharmaceutical Inc. initiated the recall on December 28, 2012 because they received a pharmacist complaint that a bottle of Ferrous Sulfate Tablets, 325 mg 07-2014, contained Meclizine HCl 25-mg tablets, NDC 0536-3990-01. Taking Meclizine HCl 25 mg as Ferrous Sulfate 325 mg may cause serious side effects to those who consume alcohol or other sedatives, those with a preexisting CNS disorder, those with imprinted kidney or liver function, the elderly, nursing infants of lactating mothers who received the drug, and newborns of mothers who received the drug immediately before childbirth.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm336107.htm?source=govdelivery

    Lactated Ringers and 5% Dextrose Injection

    Hospira, Inc. is initiating a voluntary nationwide user-level recall of one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000 mL, Flexible Container, NDC 0409-7929-09. This action is due to one confirmed customer report where a spore-like structured particulate, consistent with mold, was noted in the solution. Hospira has not received reports of any adverse events associated with this issue for this lot, and has not identified any quality issues with retention samples for this lot. If a contaminated solution is used on a patient, this may cause thrombosis, phlebitis, bacteremia, sepsis, septic shock and/or endocarditis, or result in a fatal infection in a broad array of patients. The product is used as a source of water, electrolytes, and calories or as an alkalizing agent and is packaged in a 1000 mL flexible container, lot number 05-019-JT, with an expiration date of May 1, 2013. The affected lot was distributed nationwide between June 2011 and January 2012 to wholesalers/distributors, hospitals, and pharmacies. Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm337089.htm?source= govdelivery


    Mobius Therapeutics, LLC, St. Louis, MO, has announced that it is conducting a voluntary recall of 2 lots of Mitosol (mitomycin for solution), 0.2 mg/vial, Kits for Ophthalmic Use: lots M098260 and M098260, Exp. 08/13. The company is taking this voluntary action due to the fact that they cannot exclude the possibility that the affected lots may be non-sterile. These two lots of Mitosol Kits may contain a strain of yeast on one or more parts in the kit and should be considered non-sterile and unsafe for use. The user level for this product would be physicians in hospitals and clinics during surgery. Use of these potentially contaminated products could result in serious eye problems/infections, including possible blindness. Mobius has not received any report of adverse events related to this recall. Customers with affected product in their possession should stop using the product immediately and contact Mobius.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm335055.htm?source=govdelivery

    FDA Alerts


    Otsuka and the FDA have notified healthcare professionals of significant liver injury associated with the use of Samsca (tolvaptan). In a double-blind, 3-year, placebo-controlled trial in about 1400 patients with Autosomal Dominant Polycystic Kidney Disease and its open-label extension trial, 3 patients treated with the drug developed significant increases in serum ALT with concomitant, clinically significant increases in serum total bilirubin. In the trials the maximum daily dose of Samsca administered (90 mg in the morning and 30 mg in the afternoon) was higher than the maximum 60 mg daily dose approved for the treatment of hyponatremia. Most of the liver enzyme abnormalities were observed during the first 18 months of therapy. Following discontinuation of treatment, all 3 patients improved. An external panel of liver experts assessed these 3 cases as being either probably or highly likely to be caused by tolvaptan. These findings indicate that Samsca has the potential to cause irreversible and potentially fatal liver injury. These data are not adequate to exclude the possibility that patients receiving Samsca for its indicated use of clinically significant hypervolemic and euvolemic hyponatremia are at a potential increased risk for irreversible and potentially fatal liver injury. Healthcare providers should perform liver tests promptly in patients who report symptoms that may indicate liver injury. If hepatic injury is suspected, Samsca should be promptly discontinued, appropriate treatment should be instituted, and investigations should be performed to determine probable cause. Samsca should not be re-initiated in patients unless the cause for the observed liver injury is definitively established to be unrelated to treatment with Samsca.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm336669.htm?source=govdelivery


    The FDA is notifying the public of new information about zolpidem. The FDA recommends that the bedtime dose be lowered because new data show that blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving. This announcement focuses on zolpidem products approved for bedtime use, which are marketed as generics and under the brand names Ambien, Ambien CR, Edluar, and Zolpimist. The FDA is also reminding the public that all drugs taken for insomnia can impair driving and activities that require alertness the morning after use. For zolpidem products, data show the risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs (Ambien CR and generics). Women appear to be more susceptible to this risk because they eliminate zolpidem from their bodies more slowly than men. Because use of lower doses of zolpidem will result in lower blood levels in the morning, the FDA is requiring the manufacturers of Ambien, Ambien CR, Edluar, and Zolpimist to lower the recommended dose. The FDA is continuing to evaluate the risk of impaired mental alertness with other insomnia drugs, including OTC drugs available without a prescription. The FDA urges healthcare professionals to caution all patients (men and women) who use these products about the risks of next-morning impairment for activities that require complete mental alertness, including driving.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm334738.htm?source=govdelivery

    FDA First Time Generic Approval

    Methylphenidate HCl ER

    Mallinckrodt, the Pharmaceuticals business of Covidien, has announced that it has received approval from the FDA to manufacture and market a generic version of Concerta (methylphenidate HCl) ER tablets in 27, 36, and 54 mg dosage strengths. The company will launch Methylphenidate HCl ER tablets in the 27 mg dosage strength immediately. Mallinckrodt believes it holds a separate 180-day exclusivity period for each of the 27, 36, and 54 mg dosage strengths, which begins upon commercial launch of each respective dosage strength. Mallinckrodt’s current plan is to have the 36 mg and 54 mg dosage strengths commercially available in the first calendar quarter of 2013. Mallinckrodt plans to submit a supplement to its approved abbreviated new drug application for the 18 mg dosage strength in the first calendar quarter of 2013.
    For more information, visit: investor.covidien.com/phoenix.zhtml?c=207592&p=irol-newsArticle&id=1770169