As part of our ongoing efforts to keep you informed about FDA, the Office of Health and Constituent Affairs (formerly the Office of Special Health Issues) wants to make you aware of recent safety alerts, announcements, opportunities to comment on policy issues, product approvals, upcoming meetings, and resources. We have included a list of the topics with a brief summary and links to detailed information on the FDA Web site.

October 23, 2013

PRODUCT SAFETY

Specialty Medicine Compounding Pharmacy Certain Unexpired Compounded Sterile Products: Recall - Particulate Matter Found in Vials

Specialty Medicine Compounding Pharmacy is voluntarily recalling all lots of certain unexpired human and veterinary sterile products to the consumer level due to particulate matter found in vials of a compounded dextrose injection product dispensed to a local hospital. More information

Bard LifeStent Solo Vascular Stent: Class 1 Recall - Failure to Deploy

FDA notified health professionals and medical care organizations of a class 1 recall of this product due to deployment issues that range from failure to deploy, partial deployment, and difficult deployment. More information

Albuterol Sulfate Inhalation Solution, 0.083 percent (Nephron Pharmaceuticals): Recall - Aseptic Processing Simulation Results

Nephron Pharmaceuticals initiated a voluntary recall, at the retail level, of ten lots of product due to results from an internal monitoring process. More information

Iclusig (Ponatinib): Increased Reports Of Serious Blood Clots In Arteries And Veins

FDA is investigating an increasing frequency of reports of serious and life-threatening blood clots and severe narrowing of blood vessels of patients taking the leukemia chemotherapy drug Iclusig. More information

St. Jude Amplatzer Atrial Septal Occluder (ASO): Reports of Tissue Erosion

FDA is alerting health care providers and patients that in very rare instances, tissue surrounding the Amplatzer ASO can break down (erode) and result in life-threatening emergencies that require immediate surgery. More information

Engström Ventilator, Aespire View, Aisys, And Avance Anesthesia Machines: Voluntary Field Corrective Action - Potential Safety Issue

GE Healthcare has initiated a voluntary field corrective action due to a potential safety issue that involves unresponsive buttons on the display of the Engström ventilator and Aespire View, Aisys, and Avance anesthesia machines. More information

Avance, Aisys And Avance CS2 Anesthesia Delivery Systems: Voluntary Field Corrective Action - Potential Safety Issue

GE Healthcare has initiated a voluntary field corrective for the Avance, Aisys and Avance CS2 anesthesia delivery systems with 8.00 (Avance and Aisys) or 10.00 (Avance CS2) software due to a potential safety issue. More information

Cefepime For Injection, USP And Dextrose Injection, USP By B. Braun Medical Inc.: Recall - Visible Particulate Matter

B. Braun Medical Inc. is voluntarily recalling one lot of 1g Cefepime for Injection USP and Dextrose Injection USP (Lot H3A744, catalog 3193-11) to the consumer level. More information

Hospira brand Lidocaine and Marcaine: Recall - Presence Of Particulate

Hospira announced a voluntary nationwide recall to the user level for one lot of 0.25% Marcaine (Bupivacaine HCl Injection, USP), 75 mg/30 mL, Single-dose Vial – Preservative Free (NDC 0409-1559-30), Lot 25-220-DD. More information

Comunicaciones de la FDA sobre la seguridad de los medicamentos en español

Descargo de responsabilidad: La FDA reconoce la necesidad de proporcionar información sobre seguridad importante en idiomas distintos al inglés. Hacemos lo mejor posible para proporcionar versiones en español precisas y oportunas de nuestras Comunicaciones de Seguridad de Medicamentos. Sin embargo, en caso que existiera discrepancias entre las versiones en ingles y en español, la información contenida en la versión en inglés es la que se considera como versión oficial. Si tiene alguna pregunta, por favor contáctese con Division of Drug Information en druginfo@fda.hhs.gov. Comunicaciones de la FDA

For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch

PRODUCT APPROVALS

FDA approves Opsumit to treat pulmonary arterial hypertension

FDA approved Opsumit (macitentan), a new drug to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive and debilitating disease that can lead to death or the need for lung transplantation. More information

FDA approves new pediatric use for Liposorber Apheresis System

FDA approved Liposorber LA-15 System to treat pediatric patients with primary focal segmental glomerulosclerosis (FSGS) either before transplant, or after renal (kidney) transplantation in which there is recurrence of FSGS. More information

For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA or DailyMed

OPPORTUNITIES FOR COMMENT / GUIDANCES

Draft Guidance for Industry on Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products-Content and Format

This draft guidance provides recommendations for the "Patient Counseling Information" section on the following: How to decide what topics to include in the section, how to present information within the section, and how to format and organize section contents. Submit either electronic or written comments on the draft guidance by November 18, 2013. More information

Guidance for Industry on Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment; Availability

The purpose of this guidance is to assist sponsors in the development of new antibacterial drugs to treat acute bacterial skin and skin structure infections (ABSSSI). This guidance finalizes the revised draft guidance of the same name issued on August 27, 2010. More information

Draft Guidance for Industry on Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment; Availability

The purpose of this guidance is to assist sponsors in all phases of development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C. This guidance revises and replaces a previous draft guidance for industry entitled ``Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment'' issued on September 14, 2010. Submit either electronic or written comments on the draft guidance by December 23, 2013. More information

ANNOUNCEMENTS

FDA awards 15 grants to stimulate drug, device development for rare diseases

FDA announced it has awarded 15 grants totaling more than $14 million to boost the development of products for patients with rare diseases. More information

FDA investigates acute hepatitis illnesses potentially linked to products labeled OxyElite Pro

FDA continues its investigation of acute hepatitis illnesses linked to products labeled OxyElite Pro. More information

Get the latest news and information on Twitter @FDAfood

Get the latest news and information on food, nutrition, food additives, dietary supplements, and FDA's Food Safety Modernization Act on Twitter @FDAfood. More information

Talk About Prescription Month reminder to stay safe when buying medicine online; FDA video shows you how

October is Talk about Prescriptions Month, and FDA wants you to know that medications purchased from some online pharmacies can be dangerous or even deadly. FDA is committed to protecting consumers from unlicensed "fake" online pharmacies and has developed BeSafeRx: Know Your Online Pharmacy to help. Visit the BeSafeRx Web site and watch a short video featuring FDA's Health Fraud Coordinator Gary Coody explaining how to avoid unsafe online pharmacies. More information

FDA takes enforcement action against Oregon dietary supplement manufacturer

FDA, in a complaint filed by the U.S. Department of Justice, is seeking a permanent injunction against the dietary supplement manufacturer James G. Cole, Inc., its president, James G. Cole, and its general manager, Julie D. Graves, following the company's repeated distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug, and Cosmetic Act. More information

UPCOMING MEETINGS

FDA advisory committe meetings are free and open to the public. No prior registration is required to attend. Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee.

Other types of meetings listed may require prior registration and fees. Click on "more information" for details about each meeting.

Please visit FDA's Advisory Committee webpage for more information. Please visit Meetings, Conferences, & Workshops for more information on other agency meetings.

Third Annual Food and Drug Administration Health Professional Organizations Conference (Oct 24) - POSTPONED

Topics on the agenda include FDA Updates, an overview of FDA's Network of Experts (public/private partnerships), and a FDA Town Hall. More information

Antiviral Drugs Advisory Committee Meeting (Oct 24)

The committee will discuss a new drug application simeprevir with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease who are treatment-naïve or who have failed previous interferon therapy (pegylated or non-pegylated) with or without ribavirin. More information

Antiviral Drugs Advisory Committee Meeting (Oct 25)

The committee will discuss new drug application sofosbuvir, with a proposed indication for the treatment of chronic hepatitis C infection, in combination with other agents in adult patients with genotypes 1 to 6 and/or adult patients awaiting liver transplantation. More information

Public Workshop: Clinical Trial Design for Intravenous Fat Emulsion Products (Oct 29)

Stakeholders, including industry sponsors, academia, patients receiving parenteral nutrition, and FDA, will discuss challenging issues related to selection of endpoints and assessment methodologies in registration trials. Trial design strategies and possible candidates for endpoints will be explored. More information

Blood Products Advisory Committee Meeting (Nov 1)

The committee will meet in open session to discuss MP Diagnostics HTLV Blot 2.4, a Western Blot intended for use as a confirmatory test for blood donors. The committee will hear update presentations on the following topics: (1) The April 2013 FDA public workshop on multiplex detection of transfusion transmissible agents and blood cell antigens in blood donations and (2) FDA safety communications on new boxed warnings for immune globulin products and hydroxyethyl starch solutions. More information

Allergenic Products Advisory Committee Meeting (Nov 5-6) - POSTPONED

On November 5, 2013, the committee will meet in open session to discuss and make recommendations on the safety and efficacy of Oralair. On November 6, the committee will meet to discuss and make recommendations on the safety and efficacy of Grastek. More information

Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee Meeting (Nov 8)

The committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Nucleus® Hybrid™ L24 Implant System. More information

Vaccines and Related Biological Products Advisory Committee Meeting (Nov 13)

The committee will meet in open session via teleconference to hear an overview of the research programs in the Laboratory of Retrovirus Research and the Laboratory of Immunoregulation, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. More information

Peripheral and Central Nervous System Drugs Advisory Committee Meeting (Nov 13)

The committee will discuss supplemental biologics license application alemtuzumab injection, proposed trade name LEMTRADA. The proposed indication is for the treatment of patients with relapsing forms of multiple sclerosis to slow or reverse the accumulation of physical disability and reduce the frequency of clinical exacerbations.

Peripheral and Central Nervous System Drugs Advisory Committee Meeting (Nov 14)

The committee will discuss new drug application, tasimelteon capsules, proposed trade name HETLIOZ. The proposed indication is for the treatment of Non-24 hour sleep-wake disorder in blind individuals without light perception. More information

Endocrinologic and Metabolic Drugs Advisory Committee Meeting (Nov 19)

The committee will discuss biologics license application, Vimizim (elosulfase alfa) for the treatment of Mucopolysaccharidosis Type IVA (Morquio A syndrome). More information

Public Hearing: Over-the-Counter Ophthalmic Drug Products-Emergency Use Eyewash Products (Dec 4)

The purpose of the public hearing is to obtain information on the formulation, manufacturing, and labeling of currently marketed over-the-counter (OTC) emergency first aid eyewash drug products, including the components of these products, and the conditions under which such products are safe and effective for their intended uses. More information

Joint Meeting of the Gastrointestinal Drugs Advisory Committee (GIDAC) & Drug Safety and Risk Management Advisory Committee (DSaRM) Meeting (Dec 9)

The committees will discuss two biologics license applications (BLAs) for vedolizumab injection (proposed tradename Entyvio). BLA 125476 proposes an indication for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, have lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist. BLA 125507 proposes an indication for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response to, have lost response to, or were intolerant to either conventional therapy or a TNFα antagonist.

Public Meeting: Fibromyalgia - Patient-Focused Drug Development (Dec 10)

Patient-Focused Drug Development is part of FDA's performance commitments in the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patients' perspectives on the impact of fibromyalgia on daily life as well as the available therapies for fibromyalgia. More information

Endocrinologic and Metabolic Drugs Advisory Committee Meeting (Dec 11)

The committee will discuss the safety and efficacy of biologic licensing application, metreleptin for injection. The proposed indication for metreleptin is the treatment of metabolic disorders associated with lipodystrophy, including diabetes mellitus and/or hypertriglyceridemia in pediatric and adult patients with inherited or acquired lipodystrophy. More information

RESOURCES

FDA Basics

Each month, different Centers and Offices at FDA will host an online session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA. More information

FDA Voice

FDA voice is the official blog from FDA's senior leadership and staff. More information

Medical Product Safety Network (Medsun)

Medsun improves FDA's understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns. The Medsun newsletter provides monthly updates about timely medical device issues that may impact patient safety. More information

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