U.S. FDA Drug and Product Approvals Explained: Publications and Documents
Summary
The FDA Drug and Product Approvals publications on Disabled World offer a range of articles and research relevant to medical advancements and safety. These publications include FDA announcements, research papers, and product releases covering topics such as new drug approvals like those for multiple sclerosis or Duchenne muscular dystrophy, medical device clearances such as glucose monitoring systems, and warnings regarding consumer products, like hand sanitizers or weight loss supplements. Many of the articles are peer-reviewed and offer updates, revisions, and insights that can be interesting, helpful, and of use to the general public, including seniors, people with disabilities, and those interested in staying informed about healthcare options and regulatory actions.Searching the Database
The data table below lists items that may have been updated or revised, but the table defaults to sorting by descending publication date; you can search and sort by clicking column headers (JavaScript required). Items in this category are also distributed via our U.S. FDA Drug and Product Approvals Explained RSS feed.
| Title and Description | Ed | Publish Revised |
|---|---|---|
| Cognoa ASD Diagnosis Aid Approved for Marketing by FDA Cognoa ASD Diagnosis Aid is an aid for diagnosis of ASD in patients 18 months - 5 years of age who are at risk of developmental delay based on concerns of a parent, caregiver, or health care provider. | ||
| IpsiHand Brain-Computer Stroke Rehabilitation Device FDA Approved FDA authorizes Neurolutions IpsiHand, a brain-computer interface device that uses EEG technology to help stroke patients recover hand and arm function through rehabilitation. | ✓ ✓ | |
| Safety and Effectiveness of Consumer Hand Sanitizers U.S. FDA completes series of actions on review of OTC antiseptic active ingredients and issues final rule on safety and effectiveness of consumer hand sanitizers. | ||
| Generic Version of EpiPen Approved by U.S. FDA Teva Pharmaceuticals USA gains approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths for emergency treatment of allergic reactions in adults and pediatric patients who weigh more than 33 pounds. | ||
| Scammers Target Consumers with Fake FDA Warning Letters U.S. FDA warns consumers about criminals forging FDA warning letters to target people who tried to purchase medicines online or over the phone. | ||
| FDA Approves Glucose Monitoring System with Sensor and App for Adults with Diabetes FDA approves continuous glucose monitoring system with a fully implantable glucose sensor and compatible mobile app for adults with diabetes. | ||
| Automated Insulin Delivery and Monitoring System for Younger Pediatric Patients Approved by FDA FDA approval of MiniMed 670G hybrid closed looped diabetes device to automatically monitor glucose and provide appropriate basal insulin doses for individuals aged 7 to 13 with type 1 diabetes. | ||
| US FDA Authorizes First Fully Interoperable Continuous Glucose Monitoring System US FDA has permitted marketing of Dexcom G6 integrated continuous glucose monitoring (iCGM) system for determining blood glucose levels in children aged 2 and older and adults with diabetes. | ||
| Statement From FDA Commissioner on Steps to Facilitate Efficient Generic Drug Review to Enhance Competition, Promote Access and Lower Drug Prices Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices. | ||
| FDA Permits Marketing of Device to Treat Diabetic Foot Ulcers U.S. Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers. | ||
| FDA Approves Kymriah for Cancer and Life-threatening Diseases Treatment FDA approves Kymriah, the first U.S. gene therapy, offering new hope for children and young adults with hard-to-treat acute lymphoblastic leukemia. | ✓ ✓ | |
| U.S. FDA Approves Radicava (Edaravone) to Treat ALS U.S. Food and Drug Administration approves Radicava (edaravone) to treat amyotrophic lateral sclerosis, commonly referred to as Lou Gehrig's disease. | ||
| U.S. FDA Approves Ocrevus (Ocrelizumab) to Treat Multiple Sclerosis Ocrevus (ocrelizumab) has been approved to treat adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). | ||
| Researchers Want More Transparency From the US FDA Researchers create Blueprint for Transparency to advance the development of safe and effective new products. | ||
| FDA Approves Noctiva for Frequent Night Urination Treatment Noctiva, desmopressin acetate, is a nasal spray for adults who awaken during the night to urinate (nocturnal polyuria). | ||
| FDA Approves Emflaza (Deflazacort) to Treat Duchenne Muscular Dystrophy Food and Drug Administration approves Emflaza (deflazacort) tablets and oral suspension to treat patients age 5 years and older with Duchenne muscular dystrophy. | ||
| Lawsuit Urges FDA to Protect Hair Salon Workers and Consumers from Formaldehyde Lawsuit claims U.S. FDA failed to adequately respond to concerns raised about health risks salon keratin hair products containing formaldehyde pose. | ||
| FDA Approves First Drug to Treat Duchenne Muscular Dystrophy U.S. Food and Drug Administration approves Exondys 51 (eteplirsen) injection to treat patients with Duchenne muscular dystrophy (DMD). | ||
| FDA Challenged to Support Claims Regarding Electronic Cigarettes Advocates such as E Cigarette Reviewed calling on US FDA to take evidence based approach to electronic cigarette technology. | ||
| Ethical Dilemmas Contribute to Weakness in FDA Postmarket Oversight Institute of Medicine (IOM) report recommendations for maintaining delicate balance of drug innovation and drug safety. | ||
| Insomnia Drug Intermezzo Approved by FDA US FDA approves Intermezzo zolpidem tartrate sublingual tablets for insomnia characterized by night waking followed by difficulty returning to sleep. | ||
| FDA Approves Cialis for Enlarged Prostate Treatment BPH FDA approval of tadalafil (Cialis) for benign prostatic hyperplasia symptoms and concurrent erectile dysfunction treatment in men with enlarged prostate. | ✓ ✓ | |
| Boostrix for Tetanus, Diphtheria and Pertussis in Seniors U.S. Food and Drug Administration approves Boostrix vaccine to prevent tetanus diphtheria and pertussis (whooping cough) in people ages 65 and older. | ||
| FDA Approves Lazanda (Fentanyl) Nasal Spray for Breakthrough Cancer Pain FDA approved Lazanda (fentanyl) nasal spray for management of breakthrough pain in cancer patients 18 years and older already receiving and are tolerant to opioid therapy for underlying persistent cancer pain. | ||
| Global Strategy to Help Ensure Safety and Quality of Imported Products The FDA Pathway to Global Product Safety and Quality strategy to meet challenges posed by rapidly rising imports of FDA regulated products and complex global supply chain. | ||
| Injectable Gel to Treat Fecal Incontinence Approved by FDA Sterile injectable gel to treat fecal incontinence in patients for whom other therapies such as diet change fiber therapy or anti-motility medications failed. | ||
| Toxoplasmosis Parasite Infection Test Toxoplasmosis is caused by the parasite Toxoplasma gondii and can cause serious health problems in people with compromised immune systems. | ||
| Sutent for Rare Type of Pancreatic Cancer Approved by FDA Sutent (sunitinib) approved for progressive neuroendocrine cancerous tumors located in the pancreas that cannot be removed by surgery or have spread to other parts of the body. | ||
| Q Fever Test for Military Serving Overseas Q fever is an infectious disease among serving soldiers and can cause acute or chronic illness after contact with infected animals or exposure to contaminated environments. | ||
| Edurant FDA Approved HIV Treatment The U.S. Food and Drug Administration has approved Edurant (rilpivirine) in combination with other anti-retroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy. | ||
| FDA Approves Victrelis for Hepatitis C The safety and effectiveness of Victrelis was evaluated in two phase 3 clinical trials with 1500 adult patients. | ||
| FDA Approves Tradjenta (linagliptin) for Treatment of Type 2 Diabetes U.S. Food and Drug Administration has approved Tradjenta (linagliptin) tablets a prescription medication used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. | ||
| Horizant for Restless Legs Syndrome FDA Approved FDA approved drug Horizant provides significant help in treating restless legs syndrome symptoms. | ||
| FDA Proposes Draft Menu and Vending Machine Labeling Requirements Calorie labeling on menus and menu boards in chain restaurants retail food establishments and vending machines. | ||
| Yervoy Ipilimumab Treatment for Late Stage Skin Cancer U.S. Food and Drug Administration (FDA) approves Yervoy (ipilimumab) to treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer. | ||
| Zostavax Vaccine to Prevent Shingles - FDA Approval FDA approves Zostavax a live attenuated virus vaccine for the prevention of shingles in individuals 50 to 59 years of age. | ||
| FDA Approves Edarbi for High Blood Pressure Data from clinical studies showed Edarbi tablets (azilsartan medoxomil) to be more effective in lowering 24-hour blood pressure compared with two other FDA-approved hypertension drugs. | ||
| Neuralstem Receives FDA Orphan Designation for Spinal Cord Stem Cells for Treatment of ALS Congress passed the Orphan Drug Act because it recognized that adequate drugs for many rare diseases have not been developed. | ||
| FDA Approves Viibryd to Treat Major Depressive Disorder FDA approves Viibryd tablets (vilazodone hydrochloride) to treat major depressive disorder in adults. | ||
| Natroba (Spinosad) Head Lice Treatment for Children and Adults - FDA Approval Natroba provides another option for the topical treatment of head lice infestations. | ||
| FDA Warns Consumers Not to Use Fruta Planta Weight Loss Products The FDA has received multiple reports of adverse events associated with the use of Fruta Planta and Reduce Weight Fruta Planta. | ||
| Extension of FDA Review for Cladribine Tablets for Treatment of Relapsing Forms of Multiple Sclerosis EMD Serono Announces Extension of FDA Priority Review Period for Cladribine Tablets for the Treatment of Relapsing Forms of Multiple Sclerosis. | ||
| FDA Approves Cymbalta for Chronic Musculoskeletal Pain Cymbalta a non-narcotic pain reliever has shown to significantly reduce chronic low back pain and chronic pain due to osteoarthritis. | ||
| FDA Approval of First Drug to Treat Tuberous Sclerosis Complex Tuberous Sclerosis Alliance Announces FDA Approval of First Drug to Treat Tuberous Sclerosis Complex. | ||
| PRADAX Approved for for Stroke Prevention in Canadians with Atrial Fibrillation PRADAX is an alternative for Canadians at high risk of stroke due to atrial fibrillation. | ||
| New Oral Contraceptive Also Raises Folate Levels Beyaz is the first and only OC approved to raise folate levels in women who choose an OC for birth control. | ||
| Oral Drug to Reduce MS Relapses FDA Approved FDA has approved Gilenya capsules (fingolimod) to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis (MS). | ||
| FDA Approves Krystexxa for Treatment-Resistant Gout FDA has approved Krystexxa for adults with gout unresponsive to conventional therapy, offering new hope but requiring careful monitoring for allergic reactions. | ✓ ✓ | |
| FDA Approves Pediatric Use of Chemical Poisoning Treatment The U.S. Food and Drug Administration has approved the pediatric use of Protopam Chloride. | ||
| Actavis Receives FDA Approval of Atomoxetine HCl Capsules for ADHD Actavis receives approval from FDA to market Atomoxetine HCl capsules for treatment of attention deficit hyperactivity disorder (ADHD). | ||
| FDA Approves Ella Abortion Drug as Emergency Contraceptive Ella is a drug that can cause abortions but is misleadingly labeled as an effective Emergency Contraceptive. | ||
| Public Outcry for FDA Reform A rise in undisclosed side-effects of prescription medications like Vioxx and Avandia have put the U.S. FDA under fire with consumer watch groups calling for agency reform. | ||
| FDA Approves Vaccines for 2010-2011 Influenza Season US FDA has approved vaccines for the 2010-2011 influenza season in the United States including H1N1. | ||
| New York State Approves Quest Diagnostics Fragile X Syndrome Test XSense laboratory test that may be suitable for population-based screening for Fragile X Syndrome. | ||
| Implantable Miniature Telescope Improves Sight of AMD Patients FDA has approved Implantable Miniature Telescope (IMT) to improve vision in patients with age-related macular degeneration (AMD). | ||
| Circadin Approved in EU for Treatment of Primary Insomnia Circadin is Approved in the EU for Treatment of Primary Insomnia in Patients Aged 55 or Over for up to 3 Months. | ||
| FDA Approves New Treatment for Advanced Prostate Cancer Jevtana (cabazitaxel) chemotherapy drug used in combination with steroid prednisone to treat prostate cancer. | ||
| FDA Clearance of Lactate Test FDA clearance to market new lactate test on the epoc Blood Analysis System. | ||
| FDA Advisory Committee Recommends Approval of FTY720 Fingolimod for Relapsing Remitting Multiple Sclerosis FTY720 (fingolimod) represents significant advance as efficacious MS oral treatment for people with relapsing remitting multiple sclerosis. | ||
| FDA to Review Dental Amalgam Dental amalgam is a mixture of metals composed of liquid mercury powdered amalgam alloy composed primarily of silver tin, and copper. | ||
| FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal Women Injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures. | ||
| LensAR Laser System Receives FDA Clearance for Use in Cataract Surgery Clearance from the FDA for use of the LensAR Laser System for anterior capsulotomy during cataract surgery. | ||
| FDA Clearance for Redsense Safety Device for Home use During Home Hemodialysis Redsense Medical Receives FDA Clearance for the Redsense Safety Device for Home/Self use During Home Hemodialysis. | ||
| Equal Rigor in Assessing Food Claims and Drug Approvals IOM report recommends framework to evaluate science behind health claims for foods and drugs equal rigor in assessing food claims and drug approvals. | ||
| U.S. FDA Approves Natazia, a New Oral Contraceptive for the Prevention of Pregnancy Introducing the first and only oral contraceptive to bring estradiol valerate together with dienogest in a new dosing regimen. | ||
| FDA Approves VIMOVO for At-Risk Arthritis Patients FDA approves VIMOVO for arthritis patients at risk of NSAID-associated gastric ulcers, combining naproxen pain relief with stomach protection. | ✓ ✓ | |
| FDA Approval of Asclera to Treat Varicose Veins Approval of Asclera (polidocanol) Injection a sclerotherapy treatment for uncomplicated spider and reticular veins. | ||
| Device Manufacturers to Include Information on Pediatric Populations Requirement that device manufacturers provide readily available information in certain premarket applications on pediatric patients. | ||
| FDA Approval of Differin (adapalene) Lotion for Acne Treatment Lotion formulation of the well-tolerated retinoid adapalene for the treatment of acne. |
Key: the first check mark indicates the publication carries an editor's note; the second indicates a footnote.
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