U.S. FDA New Drug and Product Approvals Document List
Updated/Revised Date : 2018-07-03
Author : Disabled World - Contact: (www.disabled-world.com)
Although some of these documents from our FDA Approvals category may have since been updated, re-written, replaced, or revised, they are sorted below by their original publish date. The most recent publications are listed at the top of the table with older articles being listed in descending order by the date they were created.
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List of FDA Approvals Publications:
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.
U.S. FDA authorizes marketing of Neurolutions IpsiHand Upper Extremity Rehabilitation System to facilitate muscle rehabilitation in stroke patients.
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.
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.
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 continuous glucose monitoring system with a fully implantable glucose sensor and compatible mobile app for adults with diabetes.
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 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.
9 : 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.
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 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. Food and Drug Administration approves Radicava (edaravone) to treat amyotrophic lateral sclerosis, commonly referred to as Lou Gehrig's disease.
Ocrevus (ocrelizumab) has been approved to treat adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS).
Researchers create Blueprint for Transparency to advance the development of safe and effective new products.
Noctiva, desmopressin acetate, is a nasal spray for adults who awaken during the night to urinate (nocturnal polyuria).
Food and Drug Administration approves Emflaza (deflazacort) tablets and oral suspension to treat patients age 5 years and older with Duchenne muscular dystrophy.
Lawsuit claims U.S. FDA failed to adequately respond to concerns raised about health risks salon keratin hair products containing formaldehyde pose.
U.S. Food and Drug Administration approves Exondys 51 (eteplirsen) injection to treat patients with Duchenne muscular dystrophy (DMD).
Advocates such as E Cigarette Reviewed calling on US FDA to take evidence based approach to electronic cigarette technology.
IOM report recommendations for maintaining delicate balance of drug innovation and drug safety.
US FDA approves Intermezzo zolpidem tartrate sublingual tablets for insomnia characterized by night waking followed by difficulty returning to sleep.
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.
U.S. Food and Drug Administration approves Boostrix vaccine to prevent tetanus diphtheria and pertussis (whooping cough) in people ages 65 and older.
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.
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.
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 is caused by the parasite Toxoplasma gondii and can cause serious health problems in people with compromised immune systems.
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 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 is used in combination with other anti-retroviral drugs for the treatment of HIV 1 infection in adults.
The safety and effectiveness of Victrelis was evaluated in two phase 3 clinical trials with 1500 adult patients.
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.
FDA approved drug Horizant provides significant help in treating restless legs syndrome symptoms.
Calorie labeling on menus and menu boards in chain restaurants retail food establishments and vending machines.
Yervoy ipilimumab treats patients with late-stage metastatic melanoma the most dangerous type of skin cancer.
FDA approves Zostavax a live attenuated virus vaccine for the prevention of shingles in individuals 50 to 59 years of age.
Data from clinical studies showed Edarbi to be more effective in lowering 24-hour blood pressure compared with two other FDA-approved hypertension drugs.
Congress passed the Orphan Drug Act because it recognized that adequate drugs for many rare diseases have not been developed.
FDA approves Viibryd tablets (vilazodone hydrochloride) to treat major depressive disorder in adults.
Natroba provides another option for the topical treatment of head lice infestations.
The FDA has received multiple reports of adverse events associated with the use of Fruta Planta and Reduce Weight Fruta Planta.
Axiron topical solution CIII for replacement therapy in men for certain conditions associated with a deficiency or absence of testosterone.
43 : 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.
Cymbalta a non-narcotic pain reliever has shown to significantly reduce chronic low back pain and chronic pain due to osteoarthritis.
Tuberous Sclerosis Alliance Announces FDA Approval of First Drug to Treat Tuberous Sclerosis Complex.
PRADAX is an alternative for Canadians at high risk of stroke due to atrial fibrillation.
Beyaz is the first and only OC approved to raise folate levels in women who choose an OC for birth control.
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 (pegloticase) to treat gout in adults who do not respond to or who cannot tolerate conventional therapy.
The U.S. Food and Drug Administration has approved the pediatric use of Protopam Chloride.
Actavis receives approval from FDA to market Atomoxetine HCl capsules for treatment of attention deficit hyperactivity disorder (ADHD).
Ella is a drug that can cause abortions but is misleadingly labeled as an effective Emergency Contraceptive.
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.
US FDA has approved vaccines for the 2010-2011 influenza season in the United States including H1N1.
XSense laboratory test that may be suitable for population-based screening for Fragile X Syndrome.
FDA has approved Implantable Miniature Telescope (IMT) to improve vision in patients with age-related macular degeneration (AMD).
Circadin is Approved in the EU for Treatment of Primary Insomnia in Patients Aged 55 or Over for up to 3 Months.
Jevtana (cabazitaxel) chemotherapy drug used in combination with steroid prednisone to treat prostate cancer.
FDA clearance to market new lactate test on the epoc Blood Analysis System.
60 : 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.
Dental amalgam is a mixture of metals composed of liquid mercury powdered amalgam alloy composed primarily of silver tin, and copper.
Injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures.
Clearance from the FDA for use of the LensAR Laser System for anterior capsulotomy during cataract surgery.
Redsense Medical Receives FDA Clearance for the Redsense Safety Device for Home/Self use During Home Hemodialysis.
Iom report recommends framework to evaluate science behind health claims for foods and drugs equal rigor in assessing food claims and drug approvals.
Introducing the first and only oral contraceptive to bring estradiol valerate together with dienogest in a new dosing regimen.
New treatment option for the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.
Approval of Asclera (polidocanol) Injection a sclerotherapy treatment for uncomplicated spider and reticular veins.
Requirement that device manufacturers provide readily available information in certain premarket applications on pediatric patients.
Increased hours during which people with Parkinsons disease have better mobility.
Lotion formulation of the well-tolerated retinoid adapalene for the treatment of acne.
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Cite Page: Journal: Disabled World. Language: English (U.S.). Author: Disabled World. Revised Publication Date: 2018-07-03. Title: U.S. FDA New Drug and Product Approvals, Source: <a href=https://www.disabled-world.com/medical/pharmaceutical/fda-2/>FDA Approvals</a>. Retrieved 2021-06-17, from https://www.disabled-world.com/medical/pharmaceutical/fda-2/ - Reference: DW#CAT2-347-E.