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    Pharmaosmosis-" Making Ur Dream Come True": Afinitor (Everolimus)

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    Shweta
    This document summarizes several new drug approvals by the FDA in May and June 2011. Ten drugs were approved in May for treating conditions such as pancreatic neuroendocrine tumors, type 2 diabetes, hepatitis C, HIV, restless leg syndrome, and prostate cancer. In June, additional drugs were approved to treat seizures, organ transplant rejection, peripheral T-cell lymphoma, pain, anal fissures and fistulas, wrinkles, and cough or nasal congestion. New formulations of existing drugs were also approved for influenza vaccination and treating gastroesophageal reflux disease in pediatric patients.

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    Pharmaosmosis-" Making Ur Dream Come True": Afinitor (Everolimus)

    Uploaded by

    Shweta
    23 views3 pages
    This document summarizes several new drug approvals by the FDA in May and June 2011. Ten drugs were approved in May for treating conditions such as pancreatic neuroendocrine tumors, type 2 diabetes, hepatitis C, HIV, restless leg syndrome, and prostate cancer. In June, additional drugs were approved to treat seizures, organ transplant rejection, peripheral T-cell lymphoma, pain, anal fissures and fistulas, wrinkles, and cough or nasal congestion. New formulations of existing drugs were also approved for influenza vaccination and treating gastroesophageal reflux disease in pediatric patients.

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    FDA Drugs 2011_01

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    This document summarizes several new drug approvals by the FDA in May and June 2011. Ten drugs were approved in May for treating conditions such as pancreatic neuroendocrine tumors, type 2 diabetes, hepatitis C, HIV, restless leg syndrome, and prostate cancer. In June, additional drugs were approved to treat seizures, organ transplant rejection, peripheral T-cell lymphoma, pain, anal fissures and fistulas, wrinkles, and cough or nasal congestion. New formulations of existing drugs were also approved for influenza vaccination and treating gastroesophageal reflux disease in pediatric patients.

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    © All Rights Reserved
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    23 views3 pages

    Pharmaosmosis-" Making Ur Dream Come True": Afinitor (Everolimus)

    Uploaded by

    Shweta
    This document summarizes several new drug approvals by the FDA in May and June 2011. Ten drugs were approved in May for treating conditions such as pancreatic neuroendocrine tumors, type 2 diabetes, hepatitis C, HIV, restless leg syndrome, and prostate cancer. In June, additional drugs were approved to treat seizures, organ transplant rejection, peripheral T-cell lymphoma, pain, anal fissures and fistulas, wrinkles, and cough or nasal congestion. New formulations of existing drugs were also approved for influenza vaccination and treating gastroesophageal reflux disease in pediatric patients.

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    of 3

    PHARMAOSMOSIS-“ MAKING UR DREAM COME TRUE”

    Afinitor (everolimus); Novartis; For the treatment of advanced


    pancreatic neuroendocrine tumors, Approved May 2011

    Sutent (sunitinib malate); Pfizer; For the treatment of pancreatic


    neuroendocrine tumors, Approved May 2011

    Tradjenta (linagliptin); Boehringer Ingelheim; For the treatment of


    type II diabetes, Approved May 2011

    Incivek (telaprevir); Vertex; For the treatment of genotype 1 chronic


    hepatitis C, Approved May 2011

    Victrelis (boceprevir); Merck; For the treatment of chronic hepatitis


    C genotype 1, Approved May 2011

    Edurant (rilpivirine); Tibotec; For the treatment of HIV-1, Approved


    May 2011

    Horizant (gabapentin enacarbil); GlaxoSmithKline; For the


    treatment of restless legs syndrome, Approved April 2011

    Zytiga (abiraterone acetate); Centocor Ortho Biotech; For the


    treatment of prostate cancer, Approved May 2011

    Vandetanib (vandetanib); Astra Zeneca; For the treatment of thyroid


    cancer, Approved April 2011

    Potiga (ezogabine)
    Date of Approval: June 10, 2011

    Company: GlaxoSmithKline and Valeant Pharmaceuticals International


    Treatment for: Seizures

    Creon (pancrelipase)
    New Dosage Form Approved: June 10, 2011

     Abbott Receives FDA Approval for Creon (pancrelipase) Infant-Specific

    SANJAY MISHRA (07814525309), KAPIL NANAKWANI (07814727760) Page 1


    PHARMAOSMOSIS-“ MAKING UR DREAM COME TRUE”

    Dosage for Patients With Exocrine Pancreatic Insufficiency Due to Cystic


    Fibrosis

    Nulojix (belatacept)
     Date of Approval: June 15, 2011
     Company: Bristol-Myers Squibb
    Company
     Treatment for: Organ Transplant -- Rejection Prophylaxis
    Istodax (romidepsin)
    New Indication Approved: June 16, 2011

     FDA Grants Accelerated Approval of Istodax As Treatment for Patients


    with Peripheral T-Cell Lymphoma Who Have Received at Least One Prior
    Therapy

     Oxecta (oxycodone) Tablets - formerly Acurox

     Date of Approval: June 17, 2011


     Company: Pfizer Inc. and Acura Pharmaceuticals Inc.
     Treatment for: Pain

    Rectiv (nitroglycerin) Ointment - formerly Cellegesic


    Date of Approval: June 22, 2011

    Company: ProStrakan Group plc


    Treatment for: Anal Fissure and Fistula

    laViv (azficel-T)
    Date of Approval: June 22, 2011

    Company: Fibrocell Science, Inc.


    Treatment for: Wrinkles

    Zutripro (chlorpheniramine, hydrocodone and pseudoephedrine) Oral Solution


    Date of Approval: June 8, 2011

    Company: Cypress Pharmaceutical, Inc.


    Treatment for: Cough and Nasal Congestion

    SANJAY MISHRA (07814525309), KAPIL NANAKWANI (07814727760) Page 2


    PHARMAOSMOSIS-“ MAKING UR DREAM COME TRUE”

    Rezira (hydrocodone and pseudoephedrine) Oral Solution


    Date of Approval: June 8, 2011
    Company: Cypress Pharmaceutical, Inc.
    Treatment for: Cough and Nasal Congestion

    Fluzone (influenza virus vaccine, inactivated)


    New Formulation Approved: May 10, 2011

    FDA Licenses Fluzone Intradermal - Sanofi Pasteur's New Influenza Vaccine


    Delivered by Intradermal Microinjection

    Nexium (esomeprazole)
    Patient Population Altered: April 29, 2011

     FDA Approves Nexium I.V. (Esomeprazole Sodium) for the Treatment


    of Gastroesophageal Reflux Disease (GERD) With Erosive Esophagitis
    in Pediatric and Adolescent Patients

    SANJAY MISHRA (07814525309), KAPIL NANAKWANI (07814727760) Page 3

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