U.S. FDA New Drug and Product Approvals Document List

List of FDA Approvals Publications:

• 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.

• Neurolutions IpsiHand Upper Extremity Rehabilitation System

  U.S. FDA authorizes marketing of Neurolutions IpsiHand Upper Extremity Rehabilitation System to facilitate muscle rehabilitation in stroke patients.

• 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.

• U.S. FDA Approves Gene Therapy for Treatment of Cancer and Life-threatening Diseases

  FDA approval brings first gene therapy to the United States with CAR T-cell therapy approved to treat certain children and young adults with B-cell 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 Urge More Transparency From 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.

• Cialis to Treat Benign Prostatic Hyperplasia Approved by FDA

  US FDA approves Cialis tadalafil to treat signs and symptoms of benign prostatic hyperplasia BPH and for treatment of erectile dysfunction ED when the conditions occur simultaneously.

• 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 Personnel 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 a New HIV Treatment Approved by FDA

  Edurant is used in combination with other anti-retroviral drugs for the treatment of HIV 1 infection in adults.

• 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.

• Treatment for a Late Stage Skin Cancer

  Yervoy ipilimumab treats 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.

• Edarbi for High Blood Pressure Approved by FDA

  Data from clinical studies showed Edarbi 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.

• FDA Approval for Axiron (testosterone) Topical Solution CIII

  Axiron topical solution CIII for replacement therapy in men for certain conditions associated with a deficiency or absence of testosterone.

• 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 New Drug for Gout

  FDA approves Krystexxa (pegloticase) to treat gout in adults who do not respond to or who cannot tolerate conventional therapy.

• 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 New Abortion Drug Ella 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

  Rise in undisclosed side-effects of prescription medications like Vioxx and Avandia have put 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 Approved VIMOVO for Arthritis Patients

  New treatment option for the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.

• 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.

• Once-Daily MIRAPEX ER Approved by FDA for Parkinson's Disease

  Increased hours during which people with Parkinsons disease have better mobility.

• FDA Approval of Differin (adapalene) Lotion for Acne Treatment

  Lotion formulation of the well-tolerated retinoid adapalene for the treatment of acne.