• New Drugs in The Market Approved by USFDA-2016

    About USFDA: The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services. It is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

    New Drug Approval: New drugs receive extensive screening & scrutiny before FDA approval in a process called a New Drug Application (NDA). New drugs are available only by prescription by a medical practitioner. A change to over-the-counter (OTC) status is a separate process, and the drug must be approved through an NDA first. A drug that is approved is said to be “safe and effective when used as directed.”

    Some very rare limited exceptions to this multi-step process involving animal testing and controlled clinical trials can be granted out of compassionate use protocols, as the case during the 2015 Ebola epidemic. Orphan Drugs may also be defined as “Drugs that are not developed by the pharmaceutical industry for economic reasons but which respond to public health need”. Classes of drugs which are created for treating rare diseases like cystic fibrosis, Wilson disease etc. are approved by the USFDA in the span of 7-10 years these drugs are known as orphan drugs. Let us now read further about new drugs approved listed disease wise.

    Lists of new drugs approved by USFDA 2016: Disease wise category

    Cardiology/Vascular Diseases:

    • Byvalson (nebivolol and valsartan) of Allergan: New drug sanctioned for the treatment of hypertension, Approved in June 2016.

    Dermatology:

    • Ameluz (aminolevulinic acid hydrochloride) of Biofrontera Pharma: For the treatment of actinic keratoses, Approved May 2016.
    • Taltz (ixekizumab) of Eli Lilly: For the treatment of plaque psoriasis, Approved March 2016.

    Endocrinology:

    • Adlyxin (lixisenatide) of Sanofi Aventis: For the treatment of type II diabetes, Approved July 2016.

    Family Medicine:

    • Onzetra Xsail (sumatriptan nasal powder) of Avanir: For the treatment of migraine, Approved January 2016.

    Hematology:

    • Afstyla (Antihemophilic Factor (Recombinant Single Chain) of CSL Behring: For the treatment of hemophillia A, Approved May 2016.
    • Idelvion (Coagulation Factor IX (Recombinant), Albumin Fusion Protein) of CSL Behring: For the treatment of hemophilia B, Approved March 2016.
    • Kovaltry [Antihemophilic Factor (Recombinant)] of Bayer: For the treatment of hemophillia A, Approved March 2016.
    • Opdivo (nivolumab) of Bristol-Myers Squibb: For the treatment of classical Hodgkin lymphoma, Approved May 2016.
    • Venclexta (venetoclax) of AbbVie: For the treatment of chronic lymphocytic leukemia with 17p deletion, Approved April 2016.

    Hepatology (Liver, Pancreatic, Gall Bladder)

    • Defitelio (defibrotide sodium) of Jazz Pharmaceuticals: For the treatment of hepatic veno-occlusive disease with renal or pulmonary dysfunction following HSCT, Approved March 2016.
    • Ocaliva (obeticholic acid) of Intercept Pharmaceuticals: For the treatment of primary biliary cholangitis, Approved May 2016.
    • Zepatier (elbasvir and grazoprevir) of Merck: For the treatment of chronic HCV genotypes 1 or 4, Approved January 2016.

    Immunology:

    • Afstyla (Antihemophilic Factor (Recombinant Single Chain) of CSL Behring: For the treatment of hemophillia A, Approved May 2016.
    • Descovy (emtricitabine and tenofovir alafenamide) of Gilead: For the treatment of HIV-1 infection, Approved April 2016.
    • Epclusa (sofosbuvir and velpatasvir) of Gilead Sciences: For the treatment of hepatitis C, Approved June 2016.
    • Odefsey (emtricitabine, rilpivirine, and tenofovir alafenamide) of Gilead Sciences: For the treatment of HIV-1 as initial therapy, Approved March 2016.
    • Taltz (ixekizumab) of Eli Lilly: For the treatment of plaque psoriasis, Approved March 2016.
    • Vaxchora (Cholera Vaccine, Live, Oral) of PaxVax: For active immunization against Cholera, Approved June 2016.

    Infections and Infectious Diseases:

    • Anthim (obiltoxaximab) of Elusys Therapeutics: For the treatment of inhalational anthrax, Approved March 2016.
    • Descovy (emtricitabine and tenofovir alafenamide) of Gilead: For the treatment of HIV-1 infection, Approved April 2016.
    • Epclusa (sofosbuvir and velpatasvir) of Gilead Sciences: For the treatment of hepatitis C, Approved June 2016.
    • Odefsey (emtricitabine, rilpivirine, and tenofovir alafenamide) of Gilead Sciences: For the treatment of HIV-1 as initial therapy, Approved March 2016.
    • Syndros (dronabinol oral solution) of Insys Therapeutics: For the treatment of anorexia associated with AIDS and nausea and vomiting associated with cancer chemotherapy, Approved July 2016.
    • Vaxchora (Cholera Vaccine, Live, Oral) of PaxVax: For active immunization against Cholera, Approved June 2016.
    • Zepatier (elbasvir and grazoprevir) of Merck: For the treatment of chronic HCV genotypes 1 or 4, Approved January 2016.

    Musculoskeletal:

    • Zinbryta (daclizumab) of Biogen: For the treatment of relapsing multiple sclerosis, Approved May 2016.

     

    Nephrology:

    • Cabometyx (cabozantinib) of Exelixis: For the treatment of advanced renal cell carcinoma, Approved April 2016.
    • Lenvima (lenvatinib) of Eisai: For the treatment of advanced renal cell carcinoma, Approved May 2016.
    • Rayaldee (calcifediol) of Opko Health: For the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease, Approved June 2016.

    Neurology:

    • Briviact (brivaracetam) of UCB: For the treatment of partial onset seizures related to epilepsy, Approved February 2016.
    • Nuplazid (pimavanserin) of Acadia Pharmaceuticals: For the treatment of hallucinations and delusions associated with Parkinson’s disease, Approved April 2016.
    • Nuplazid (pimavanserin) of Acadia Pharmaceuticals: For the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis, Approved May 2016.
    • Onzetra Xsail (sumatriptan nasal powder) of Avanir: For the treatment of migraine, Approved January 2016.
    • Troxyca ER (oxycodone + naltrexone) of Pfizer: For the management of severe pain, Approved August 2016.
    • Zinbryta (daclizumab) of Biogen: For the treatment of relapsing multiple sclerosis, Approved May 2016.

    Oncology:

    • Cabometyx (cabozantinib) of Exelixis: For the treatment of advanced renal cell carcinoma, Approved April 2016.
    • Keytruda (pembrolizumab) of Merck: For the treatment of head and neck squamous cell cancer, Approved August 2016.
    • Lenvima (lenvatinib) of Eisai: For the treatment of advanced renal cell carcinoma, Approved May 2016.
    • Opdivo (nivolumab) of Bristol-Myers Squibb: For the treatment of classical Hodgkin lymphoma, Approved May 2016.
    • Sustol (granisetron) of Heron Therapeutics: For the prevention of chemotherapy-induced nausea and vomiting, Approved August 2016.
    • Syndros (dronabinol oral solution) of Insys Therapeutics: For the treatment of anorexia associated with AIDS and nausea and vomiting associated with cancer chemotherapy, Approved July 2016.
    • Tecentriq (atezolizumab) of Genentech: For the treatment of urothelial carcinoma, Approved May 2016.
    • Venclexta (venetoclax) of AbbVie: For the treatment of chronic lymphocytic leukemia with 17p deletion, Approved April 2016.

    Ophthalmology:

    • Humira (adalimumab) of Abbvie: For the treatment of uveitis, Approved July 2016.
    • Xiidra (lifitegrast) of Shire: For the treatment of dry eye disease, Approved July 2016.

    Pediatrics/Neonatology:

    • Kovaltry [Antihemophilic Factor (Recombinant)] of Bayer: For the treatment of hemophilia A, Approved March 2016.

    Pharmacology/Toxicology:

    • Sustol (granisetron) of Heron Therapeutics: For the prevention of chemotherapy-induced nausea and vomiting, Approved August 2016.

    Psychiatry/Psychology:

    • Nuplazid (pimavanserin) of Acadia Pharmaceuticals: For the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis, Approved May 2016.

    Pulmonary/Respiratory Diseases:

    • Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) of AstraZeneca: For the treatment of chronic obstructive pulmonary disease, Approved April 2016.
    • Cinqair (reslizumab) of Teva Pharmaceuticals: For the treatment of severe asthma, Approved March 2016.

    Urology:

    • Tecentriq (atezolizumab) of Genentech: For the treatment of urothelial carcinoma, Approved May 2016.

    Vaccines:

    Vaxchora (Cholera Vaccine, Live, Oral) of PaxVax: For active immunization against Cholera, Approved June 2016.

    Categories: Blog for Doctors, CME & Education, Doctors Daily, Health Articles

    Tags: , , , , ,

    Leave a Reply

    Your email address will not be published. Required fields are marked *