Patient Network News

This bi-weekly newsletter provided by the Office of Special Health Issues at the Food and Drug Administration (FDA) is intended to inform you of FDA-related information on a variety of topics, including new product approvals,significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other information of interest to patients and patient advocates. Subscribe or update your subscriber preferences.   Volume 2 | Number 5 | February 22, 2012 McNeil Consumer Healthcare Announces Voluntary Nationwide Recall of Intants' Tylenol Oral Suspension. McNeil Consumer Healthcare, is voluntarily recalling, at the wholesale and retail levels, seven lots, approximately 574,000 bottles, of Infants' TYLENOL Oral Suspension, 1 oz. Grape distributed nationwide in the United States (see full product list below). Infants' TYLENOL is an over-the-counter (OTC) product indicated as a pain reliever/fever reducer. More information Regeneca, Inc. Issues a Voluntary Nationwide Recall of A Specific Lot Of RegenArouse Because of Potentional Health Risks Regeneca, Inc. announced today that it is conducting a voluntary nationwide recall of RegenArouse, Lot Number 130100, because FDA lab analysis has confirmed the presence of Tadalafil making these products unapproved new drugs. Tadalafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). More information Wholistic Herbs, Inc. Recalls "Koff & Kold" and "Kold Sore" Because Of Possible Health Risk Wholistic Herbs Inc. of Dallas, TX, is recalling all quantities of the following two, 1 fl. oz. spray products distributed from March 2009 through February 2012. Products intended for use in the eye that are non-sterile have the potential to cause eye infections, which may be sight threatening. More information FDA Drug Safety Communication: Important drug interaction between Victrelis (boceprevir) and ritonavir-boosted Human Immunodeficiency Virus (HIV) protease inhibitor drugs FDA is notifying healthcare professionals and patients that drug interactions between the hepatitis C virus (HCV) protease inhibitor Victrelis (boceprevir) and certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors (atazanavir, lopinavir, darunavir) can potentially reduce the effectiveness of these medicines when they are used together. More information FDA Drug Safety Communication: Clostridium difficile-associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs) FDA is informing the public that the use of stomach acid drugs known as proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridium difficile–associated diarrhea (CDAD). More information   Availability of Spanish language versions of Drug Safety Communications CDER's Office of Communications has launched a new pilot program to provide Spanish language versions of the agency's Drug Safety Communications (DSCs). Given various time and review constraints, the Spanish version DSCs will generally follow the English version by about 1-2 weeks. More information   For more product safety information, please visit our MedWatch website at http://www.fda.gov/medwatch   FDA recognizes the significant public health consequences that can result from drug shortages and takes tremendous efforts within its legal authority to address and prevent drug shortages. These shortages occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. When quality/manufacturing and quality problems, delays, and discontinuations. When quality/manufacturing issues are discovered by the company or the public and reported to FDA or are found by FDA upon inspection, the FDA works closely with the firm to address risks involved to prevent harm to patients.  FDA also considers the impact a shortage would have on patient care and access and works with the firm to restore supplies while also ensuring safety for patients. More information Drug Shortages Voluntarily Reported by Manufacturers During the Past 2 Weeks: Corticorelin Ovine Triflutate Etomidate Injection Zinc Injection Drug Shortages Resolved During the Past 2 Weeks: Isoniazid Tablets Sodium Chloride 14.6% Injection Vincristine Sulfate For more information about the above drugs and the complete list of drug shortages, see Current Drug Shortages.   FDA Approves Korlym for patients with endogenous Cushing's syndrome Korlym (mifepristone) was approved by the FDA to control high blood sugar levels (hyperglycemia) in adults with endogenous Cushing's syndrome. This drug was approved for use in patients with endogenous Cushing's syndrome who have type 2 diabetes or glucose intolerance and are not candidates for surgery or who have not responded to prior surgery. More information FDA approves Zioptan to treat elevated eye pressure FDA approved Zioptan (tafluprost ophthalmic solution) to help reduce elevated eye pressure in people with open-angle glaucoma. The drug is also approved for use in patients with higher-than-normal eye pressure (ocular hypertension), an important risk factor for glaucoma, the second leading cause of blindness in the United States. Patients with ocular hypertension frequently are considered to have a greater chance of developing glaucoma. More information For information on drug approvals or to view drug labeling, please visit Drugs@FDA.     Draft Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices; Availability This draft guidance responds to stakeholder requests for specific guidance on FDA's current views on how manufacturers and distributors (firms) of prescription of human and animal drug products and medical devices can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use (off-label information) related to their FDA-approved or cleared products. Comments are due by February 28, 2012. More information Draft Guidance for Industry and Food and Drug Administration Staff; the Content of Investigational Device Exemption and Premarket Approval Applications for Artificial Pancreas Device Systems; Availability This draft guidance document provides industry and the Agency staff with guidelines for developing premarket submissions for artificial pancreas device systems, in particular, the Control-to-Range (CTR) and Control-to-Target (CTT) device systems. Comments due by March 5, 2012. More information Public Workshop for Pediatric Medical Devices: Reopening of Comment Period FDA is reopening the comment period for the notice entitled ``Pediatric Medical Devices; Public Workshop; Request for Comments'' that appeared in the Federal Register of Tuesday, November 1, 2011 (76 FR 67463) until March 5, 2012. In the notice, FDA announced a public workshop to consider factors affecting the use of scientific research data to support pediatric medical device efficacy claims. More information Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and FDA Staff; FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations; Extension of Comment Period FDA requested comments on the draft guidance that has been developed to promote the initiation of clinical investigations to evaluate the medical devices under FDA's Investigational Device Exemptions (IDE) regulations. Comments due by March 9, 2012. More information FDA Proposes Draft Guidelines Intended to Improve the Representation of Women in Medical Device Clinical Trials Draft guidance aimed to address the historic under representation of women in clinical studies was issued by FDA. Intended for medical device developers and manufacturers, the guidance outlines agency recommendations for designing and conducting device clinical studies that may enhance the enrollment of women in such studies, if appropriate. Comments due by March 16, 2012. More information Draft Guidance for Industry and FDA Staff; Evaluation of Sex Differences in Medical Device Clinical Studies The purpose of this guidance is to outline the Center for Devices and Radiological Health's (CDRH) expectations regarding sex-specific patient enrollment, data analysis, and reporting of study information. Comments due March 19, 2012. More information Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies; Availability FDA is announcing the availability of a draft guidance for industry entitled `Use of Histology in Biomarker Qualification Studies. This guidance is intended to assist sponsors that conduct biomarker qualification studies for which histology is a reference standard. Comments due by March 29, 2012. FDA issues draft guidance on biosimilar product development FDA issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States. More information Draft Guidance for Industry and Food and Drug Administration Staff; the Content of Investigational Device Exemption and Premarket Approval Applications for Artificial Pancreas Device Systems; Availability This draft guidance document provides industry and the Agency staff with guidelines for developing premarket submissions for artificial pancreas device systems, in particular, the Control-to-Range (CTR) and Control-to-Target (CTT) device systems. Comments due by March 5, 2012. More information Public Workshop for Pediatric Medical Devices: Reopening of Comment Period FDA is reopening the comment period for the notice entitled ``Pediatric Medical Devices; Public Workshop; Request for Comments'' that appeared in the Federal Register of Tuesday, November 1, 2011 (76 FR 67463) until March 5, 2012. In the notice, FDA announced a public workshop to consider factors affecting the use of scientific research data to support pediatric medical device efficacy claims. More information Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and FDA Staff; FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations; Extension of Comment Period FDA requested comments on the draft guidance that has been developed to promote the initiation of clinical investigations to evaluate the medical devices under FDA's Investigational Device Exemptions (IDE) regulations. Comments due by March 9, 2012. More information FDA Proposes Draft Guidelines Intended to Improve the Representation of Women in Medical Device Clinical Trials Draft guidance aimed to address the historic underrepresentation of women in clinical studies was issued by FDA. Intended for medical device developers and manufacturers, the guidance outlines agency recommendations for designing and conducting device clinical studies that may enhance the enrollment of women in such studies, if appropriate. Comments due by March 16, 2012. More information Draft Guidance for Industry and FDA Staff; Evaluation of Sex Differences in Medical Device Clinical Studies The purpose of this guidance is to outline the Center for Devices and Radiological Health's (CDRH) expectations regarding sex-specific patient enrollment, data analysis, and reporting of study information. Comments due March 19, 2012. More information Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies; Availability FDA is announcing the availability of a draft guidance for industry entitled `Use of Histology in Biomarker Qualification Studies. This guidance is intended to assist sponsors that conduct biomarker qualification studies for which histology is a reference standard. Comments due by March 29, 2012. FDA issues draft guidance on biosimilar product development FDA issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States. More information FDA acts to bolster supply of critically needed cancer drugs. FDA announced a series of steps to increase the supply6 of critically needed cancer drugs and build on President Obama's Executive Order to help prevent future drug shortages. To hear a replay of the drug shortage briefing available until March 21, 2012 call 800-839-8792 or for international stakeholders, call 203-369-8792. The pass-code is 24569. More information   Grapefruit Juice and Medicine May Not Mix Grapefruit juice can be part of a healthful diet—most of the time. It has vitamin C and potassium substances your body needs to work properly. But it isn't good for you when it affects the way your medicines work. Grapefruit juice and fresh grapefruit can interfere with the action of some prescription drugs, as well as a few non-prescription drugs. More information FDA Seeks $4.5 billion to support medical product development, protect patients and ensure safety of the food supply The U.S. Food and Drug Administration is requesting a budget of $4.5 billion to protect and promote the public health as part of the President's fiscal year (FY) 2013 budget – a 17 percent increase over the FDA enacted budget for FY 2012. Industry user fees would fund 98 percent of the proposed budget increase. The FY 2013 request covers the period from Oct. 1, 2012 through Sept 30, 2013. More information New Jersey company agrees to halt production of unapproved dental devices Accurate Set Inc., of Newark, N.J., and the company's president and owner, Cornell L. Adams, have agreed to stop manufacturing and distributing medical devices as part of a consent decree of permanent injunction. More information FDA investigating illegal online sales of handheld dental X-ray units FDA is warning dental and veterinary professionals to not purchase or use certain potentially unsafe hand-held dental X-ray units. The FDA is concerned that these devices may not be safe or effective and could expose the user and the patient to unnecessary and potentially harmful X-rays. More information 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. Please contact the person listed for each meeting for more information about how to submit comment, testimony or other information. Cardiovascular and Renal Drugs Advisory Committee Meeting Date: February 23, 2012 The committee will discuss new drug application (NDA) 203202, proposed trade name NORTHERA (droxidopa capsules), submitted by Chelsea Therapeutics, Inc., for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure (Parkinson's Disease, Multiple System Atrophy, and Pure Autonomic Failure), Dopamine Beta-Hydroxylase Deficiency, and Non-Diabetic Autonomic Neuropathy. More information Pulmonary-Allergy Drugs Advisory Committee Meeting Date: February 23, 2012 The committee will discuss new drug application 202450, for aclidinium bromide, sponsored by Forest Laboratories, for the proposed indication of long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. More information Dermatologic and Ophthalmic Drugs Advisory Committee Meeting Date: February 27, 2012 The committee will be asked to comment on the following topics related to the use of ophthalmic drug products (products intended for use in the eye): 1) appropriate types of clinical evidence for developing anti-inflammatory drugs for the treatment of post-operative inflammation and reduction of ocular (eye) pain in patients who have undergone ocular surgery. This will include a discussion of the definition and scope of this indication as well as the types of clinical trials needed to support approval; and 2) appropriateness of marketing a single bottle of ophthalmic product for use in both eyes for post-surgical indications as it relates to the potential risk for infection. More information Vaccines and Related Biological Products Advisory Committee Meeting Dates: February 28 - 29, 2012 On February 28, 2012, the committee will hear an overview of the research program in the Laboratory of Mycobacterial Diseases and Cellular Immunology, Division of Bacterial, Parasitic and Allergenic Products, Office of Vaccines Research and Review, Center of Biologics Evaluation and Research, FDA. The committee will then discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2012-2013 influenza season. The committee will also hear an update on Pandemic Influenza Surveillance. On February 29, 2012 the committee will discuss licensure pathways for pandemic influenza vaccines. More information FDA Rare Disease Patient Advocacy Day Date: March 1, 2012 Organizations around the world are observing February 29, 2012, as the fifth annual Rare Disease Day to help raise awareness about rare diseases, which together impact millions of people worldwide. It also highlights the importance of research to develop diagnostics and treatments to address unmet medical needs. FDA is committed to advancing rare disease therapies through the devel­opment of orphan products. There are about 7000 rare diseases that collectively affect over 30 million Americans. It is estimated that about 80 percent of rare diseases are genetic, and about half of all rare diseases affect children. When congress passed the Orphan Drug Act (ODA) into law, no one could have imagined it would become one of the most important pieces of health care legislation today. More than 390 orphan products for treatment of rare diseases have been approved by FDA since this groundbreaking legislation went into effect.      FDA Office of Orphan Products Development (OOPD) grants orphan drug designation to qualified products and administers a clinical trials grant program to encourage development of treatments for orphan diseases. In addition to these programs, priority reviews and accelerated approvals of marketing applications are available to help speed needed treatments to market. The Humanitarian Use Device (HUD) and Humanitarian Device Exemption (HDE) marketing pathway creates an alternative pathway for getting market approval for medical devices that may help people with rare diseases or conditions. And FDA works with other government agencies such as the National Institutes of Health (NIH) and the European Medicines Agency to pursue common goals in the development of products for rare diseases.      Various FDA offices work closely with patients and patient organizations, including the Office of Special Health Issues, that helps brings patients' voices, including those with rare diseases, into the drug development and review process through the patient representative program. In February 2010, FDA created a position, the Associate Director for Rare Diseases in the Center for Drug Evaluation and Research, to assist stakeholders and developers of drug and biologic products in navigating the complex regulatory requirements for bringing safe and effective treatments to patients.In recognition of Rare Disease Day, on March 01, 2012, FDA will host "FDA Rare Disease Patient Advocacy Day" to engage and educate the rare disease community on regulatory processes related to rare diseases. This educational meeting will include presentations provided by FDA experts from various Centers and Offices, as well as from outside experts. The program will also be webcast. More information       The FDA Rare Disease Patient Advocacy Day is also supported by the National Institutes of Health, the National Organization for Rare Disorders, and the Genetic Alliance. Additionally, in celebration of Rare Disease Day on February 29, 2012, the FDA will join the NIH in a program to highlight the various rare diseases research activities supported by the NIH Office of Rare Diseases Research, the NIH Clinical Center, other NIH Institutes and Centers, the National Organization for Rare Disorders, and the Genetic Alliance. Rare Disease Day at NIH will be held in the Masur Auditorium from 8:30 am to 5:00 pm. More information Public Workshop: Cardiovascular Metallic Implants - Corrosion, Surface Characterization, and Nickel Leaching Dates: March 8 - 9, 2012 FDA) is announcing a public workshop on Cardiovascular Metallic Implants: Corrosion, Surface Characterization, and Nickel Leaching. The purpose of this workshop is to provide a forum for FDA, cardiovascular device manufacturers, test houses, and academia to discuss corrosion, surface characterization, and nickel leach testing, as well as collect comments and input regarding when these assessments may be considered. More information Arthritis Advisory Committee Meeting Date: March 12, 2012 The committee will discuss the anti-nerve growth factor (Anti-NGF) drug class that is currently under development and the safety issues possibly related to these drugs. These drugs are being developed for the treatment of a variety of chronic painful conditions including osteoarthritis, chronic lower back pain, diabetic peripheral neuropathy, post-herpetic neuralgia, chronic pancreatitis, endometriosis, interstitial cystitis, vertebral fracture, thermal injury, and cancer pain. More information   Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting Date: March 14, 2012 The committee will discuss the clinical pharmacology aspects of pediatric clinical trial design and dosing to optimize pediatric drug development. FDA will seek input on how to strategically inform pediatric clinical trial design and dosing by utilizing existing knowledge, including available adult and nonclinical data. More information Oncologic Drugs Advisory Committee Meeting Date: March 20, 2012 During the morning session, the committee will discuss supplemental New Drug Application (sNDA) 022465/S-010, with the trade name Votrient (pazopanib hydrochloride) tablets, application submitted by Glaxo Wellcome Manufacturing Pte Ltd doing business as GlaxoSmithKline. The proposed indication (use) for this product is for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. The phase 3 STS trial population excluded patients with adipocytic STS or gastrointestinal stromal tumors (GIST). During the afternoon session, the committee will discuss New Drug Application (NDA) 022576, with the proposed trade name Taltorvic (ridaforolimus) tablets, application submitted by Merck Sharp & Dohme Corp. The proposed indication (use) for this product is for the treatment of adult and pediatric patients (aged 13 through 17 years with weight over 100 lb or 45.4 kg) with metastatic soft tissue sarcoma or bone sarcoma as a maintenance therapy for patients who have completed at least 4 cycles of chemotherapy without evidence of disease progression. More information Oncologic Drugs Advisory Committee Meeting Date: March 21, 2012 The committee will discuss New Drug Application (NDA) 202497, with the proposed trade name Marqibo (vincristine sulfate liposomes injection), application submitted by Talon Therapeutics, Incorporated. The proposed indication (use) for this product is for the treatment of adult patients with Philadelphia Chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more treatment lines of anti-leukemia therapy. More information   Neurological Device Panel of the Medical Devices Advisory Committee Meeting Announcement Date: March 23, 2012 The committee will discuss current knowledge about the safety and effectiveness of the Wingspan Stent System with Gateway PTA Balloon Catheter for the treatment of intracranial arterial stenosis. More information Endocrinologic and Metabolic Drugs Advisory Committee Meeting Dates: March 28 - 29, 2012 On both days, the committee will discuss the role of cardiovascular assessment in the preapproval and postapproval settings for drugs and biologics developed for the treatment of obesity. More information Reproductive Health Drugs Advisory Committee Meeting Announcement Date: April 5, 2012 The Committee will discuss the benefits and risks of mirabegron (YM178), under New Drug Application (NDA) 202611, submitted by Astellas Pharma Global Development Inc. for the proposed indication of treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. More information Public Workshop: Role of Naloxone in Opioid Overdose Fatality Prevention Date: April 12, 2012 FDA, in collaboration with the Office of the Assistant Secretary for Health, National Institutes of Drug Abuse, and the Centers for Disease Control and Prevention, is announcing a scientific workshop to initiate a public discussion about the potential value of making naloxone more widely available outside of conventional medical settings to reduce the incidence of opioid overdose fatalities. More information   Please visit FDA's Advisory Committee page to obtain advisory committee meeting agendas, briefing materials, and meeting rosters prior to the meetings. You may also visit this page after meetings to obtain transcripts, presentations, and voting results. For additional information on other agency meetings please visit Meetings, Conferences, & Workshops.     MedWatch Safety Alerts for Human Medical Products Your FDA gateway for finding clinically important safety information and reporting serious problems with human medical products Device Use Safety Tips Medical Device Safety Tips highlight what can go wrong if labeling is overlooked or not followed, and provide advice on how to mitigate risks.   FDA Patient Safety News FDA Patient Safety News is a televised series that features information on new drugs, biologics and medical devices, on FDA safety notifications and product recalls that, while geared for health care providers, may be interesting and informative to patients. Consumer Updates Timely and easy-to-read articles covering all FDA activities and regulated products. 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.

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