As part of our ongoing efforts to keep you informed about FDA, the Office of Health and Constituent Affairs 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.
December 31, 2014
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IV Solutions from Wallcur of San Diego: CDER Statement - FDA Warns Health Care Professionals Not to Inject Patients
FDA is alerting health care professionals not to use Wallcur, LLC, simulated intravenous products in human or animal patients. These products are for training purposes only. There have been reports of serious adverse events associated with the use of certain products – i.e., Practi IV Solution Bags. More information
Caramel Apples: Warning - Illnesses, Including Deaths, Linked to Listeria Monocytogenes Contamination
FDA is notifying healthcare professionals and their medical care organizations of the ongoing investigation of an outbreak of listeriosis linked to commercially-produced, prepackaged caramel apples. The CDC reports that 29 people in 10 states have been reported as being infected with the outbreak strains of Listeria monocytogenes, with all 29 ill people hospitalized and five deaths reported. Nine illnesses were pregnancy-related. More information
Mitoxantrone by Hospira: Recall - Confirmed Subpotency and Out-Of-Specification
Hospira, Inc. has initiated a worldwide voluntary recall to the user level of 10 lots of MitoXANTRONE (both human and veterinary), due to confirmed subpotency and elevated impurity levels. More information
B-Lipo Capsules by Bethel Nutritional Consulting, Inc.: Recall - Undeclared Drug Ingredient
Bethel Nutritional Consulting, Inc. is recalling one lot of B-Lipo Capsules to the consumer level. A sample of B-Lipo Capsules collected and tested by the FDA was found to contain lorcaserin, a controlled substance used for weight loss. More information
SLIM-K Capsules by Bethel Nutritional Consulting, Inc.: Recall - Undeclared Drug Ingredients
Bethel Nutritional Consulting, Inc. is recalling one lot of SLIM-K Capsules to the consumer level. A sample of SLIM-K collected and tested by the FDA was found to contain sibutramine, desmethylsibutramine, and phenolphthalein.More information
For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch
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 firstname.lastname@example.org. Comunicaciones de la FDA
PRODUCT APPROVALS & CLEARANCES
FDA approves weight-management drug Saxenda
FDA approved Saxenda (liraglutide [rDNA origin] injection) as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity. The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obesity) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as hypertension, type 2 diabetes, or high cholesterol (dyslipidemia). More information
FDA approves Opdivo for advanced melanoma
FDA granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with unresectable or metastatic melanoma who no longer respond to other drugs.More information
FDA approves Rapivab to treat flu infection
Rapivab is an inhibitor of influenza virus neuraminidase, an enzyme that releases viral particles from infected cells. Rapivab is the first neuraminidase inhibitor approved for intravenous administration and is administered as a single IV dose. It is intended for patients 18 years and older who have acute uncomplicated influenza and have shown symptoms of flu for no more than two days. More information
FDA approves new antibacterial drug Zerbaxa
Zerbaxa is a combination product containing ceftolozane, a cephalosporin antibacterial drug, and tazobactam, a beta-lactamase inhibitor. More information
FDA approves Viekira Pak to treat hepatitis C
Viekira Pak contains three new drugs—ombitasvir, paritaprevir and dasabuvir—that work together to inhibit the growth of HCV. It also contains ritonavir, which is used to increase blood levels of paritaprevir. Viekira Pak can be used with or without ribavirin, but it is not recommended for patients with decompensated cirrhosis. More information
FDA approves Lynparza to treat advanced ovarian cancer
Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor that blocks enzymes involved in repairing damaged DNA. It is intended for women with heavily pretreated ovarian cancer that is associated with defective BRCA genes. More information
FDA approves pathogen reduction system to treat platelets
FDA approved the Intercept Blood System for platelets, the first pathogen reduction system to treat single donor apheresis platelets. The system is for use by blood establishments that collect and manufacture blood and blood components to prepare pathogen reduced platelets for transfusion to reduce the risk of transfusion-transmitted infections. More information
FDA approves Xtoro to treat swimmer's ear
Xtoro is an eardrop approved to treat acute otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus. Xtoro is the newest drug belonging to the fluoroquinolone antimicrobial drug class to be approved by the FDA. 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
Drug Supply Chain Security Act- Compliance Policy: Guidance for Industry
This guidance addresses the readiness of the pharmaceutical distribution supply chain to comply with the provisions in section 582 of the FD&C Act related to the exchange of product tracing information. More information
Bioequivalence Recommendations for Concerta (Methylphenidate Hydrochloride) Extended-Release Tablets: Draft Guidance for Industry
A draft guidance for industry entitled "Bioequivalence Recommendations for CONCERTA (methylphenidate hydrochloride) Extended-Release Tablets" is available for comment. The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) that reference the listed drug Concerta (methylphenidate hydrochloride (HCl)) extended-release tablets (new drug application (NDA) 021121). The draft guidance is a revised version of a previously issued draft guidance on the same subject. More information
FDA Commissioner Margaret A. Hamburg's statement on FDA's blood donor deferral policy for men who have sex with men
The recommended change is consistent with the recommendation of an independent expert advisory panel, the HHS Advisory Committee on Blood and Tissue Safety and Availability, and will better align the deferral period with that of other men and women at increased risk for HIV infection. More information
Tragic Deaths Highlight the Dangers of Powdered Pure Caffeine
After learning of the tragic deaths of two young men, the FDA posted a consumer advisory warning of the dangers of consuming powdered pure caffeine. Symptoms of caffeine overdose include rapid or erratic heartbeat and seizures.
We are working right now on our next steps. In the meantime, it is important to avoid using powdered pure caffeine. The people most drawn to it are our children, teenagers, and young adults, especially students who want to work longer to study, athletes who want to improve their performance, and others who want to lose weight. More information
Sentinel Initiative: another important step in FDA's journey towards enhanced safety through full-scale "active surveillance"
They say the longest journey begins with a single step. In 2008, FDA launched the Sentinel Initiative and thus began a long journey toward the challenging goal of developing a full-scale medical product safety monitoring program using an important scientific technique called "active surveillance," which complements our FDA Adverse Event Reporting System. More information
CDER Webinar - Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers
The recorded webinar provides an overview of the reporting requirements for wholesale distributors and third-party logistics providers under DSCSA, describes who must report to FDA, what information should be submitted to FDA, the timing of the submissions, a preferred format for the submissions, and a preferred method for reporting to FDA. Webinar recording and More information.
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FDA advisory committee 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.
The committee will discuss biologics license application (BLA) 125553 for EP2006, a proposed biosimilar to Amgen Inc.'s NEUPOGEN (filgrastim), submitted by Sandoz, Inc. More information
Framework for Regulatory Oversight of Laboratory Developed Tests; Public Workshop; Request for Comments (Jan 8 & 9)
The purpose of this workshop is to discuss FDA's proposal for a risk-based framework for addressing the regulatory oversight of a subset of in vitro diagnostic devices (IVDs) referred to as laboratory developed tests (LDTs), which are intended for clinical use and designed, manufactured and used within a single laboratory, and provide an additional opportunity for public comment. More information
Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement (Jan 12)
The committee will discuss the safety and efficacy of new drug application (NDA) 022517, proposed trade name NOCDURNA (established name: desmopressin), orally disintegrating sublingual tablets submitted by Ferring Pharmaceuticals, Inc. The proposed indication is treatment of nocturia due to nocturnal polyuria in adults who awaken two or more times each night to void. More information
The committee will discuss new drug applications (NDAs) 207-500 and 207-501, isavuconazonium sulfate capsules and isavuconazonium sulfate for injection, sponsored by Astellas Pharma Global Development, Inc., respectively for the proposed indications of treatment of invasive aspergillosis and mucormycosis. More information
Orthopaedic and Rehabilitation Devices Panel (Feb 20)
The committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Superion InterSpinous Spacer device sponsored by Vertiflex Incorporated. More information
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (Feb 27)
The committee will discuss, make recommendations and vote on information regarding the premarket approval application (PMA) panel-track supplement to expand the indication for use for the Radiesse Injectable Implant (Radiesse) device to include subdermal implantation for hand augmentation to correct volume deficit in the hands. More information
MedWatchLearn - Practice Reporting to FDA!
This web-based learning tool teaches students, health professionals, and consumers how to complete the forms necessary to report problems to FDA. More information
FDA Expert Commentary and Interview Series on Medscape
As part of the continuing collaboration between FDA and Medscape, a series of interviews and commentaries are available to communicate important safety information to clinicians. Featuring FDA experts, these original commentaries cover a wide range of topics related to FDA's multi-faceted mission of protecting and promoting the public health by ensuring the safety and quality of medical products such as drugs, foods, and medical devices More information
Cardiovascular and Endocrine Liaison Program
The Cardiovascular and Endocrine Liaison Program serves as a liaison between the FDA and the cardiovascular and endocrine health professional and patient communities. Discover how you or your organization can collaborate with FDA. More information
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 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