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    CT Approval Status 2013

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    syed
    This document provides information on 7 clinical trials approved in 2013 for drugs using recombinant DNA technology. It includes the file number, name of the firm conducting the trial, name of the drug, title of the study, and date of approval. The clinical trials approved involved drugs for conditions such as acute ischemic stroke, rheumatoid arthritis, breast cancer, and acute myocardial infarction.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    CT Approval Status 2013

    Uploaded by

    syed
    40 views2 pages
    This document provides information on 7 clinical trials approved in 2013 for drugs using recombinant DNA technology. It includes the file number, name of the firm conducting the trial, name of the drug, title of the study, and date of approval. The clinical trials approved involved drugs for conditions such as acute ischemic stroke, rheumatoid arthritis, breast cancer, and acute myocardial infarction.

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    Clinical Trails Approvals

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    This document provides information on 7 clinical trials approved in 2013 for drugs using recombinant DNA technology. It includes the file number, name of the firm conducting the trial, name of the drug, title of the study, and date of approval. The clinical trials approved involved drugs for conditions such as acute ischemic stroke, rheumatoid arthritis, breast cancer, and acute myocardial infarction.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    40 views2 pages

    CT Approval Status 2013

    Uploaded by

    syed
    This document provides information on 7 clinical trials approved in 2013 for drugs using recombinant DNA technology. It includes the file number, name of the firm conducting the trial, name of the drug, title of the study, and date of approval. The clinical trials approved involved drugs for conditions such as acute ischemic stroke, rheumatoid arthritis, breast cancer, and acute myocardial infarction.

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    © All Rights Reserved
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    Permission given for clinical trial (r-DNA based Drug Product) (2013)

    S.NO. File No. Name of Firm Name of Drug Title of The Study Date of
    Product Approval

    1 4-73/Reliance/10-BD Reliance life Reteplase (RTPR- “A Prospective multicentric single 4-Mar-13


    science pvt. Ltd 004) arm, clinical study to evaluate
    effocacu amd saferu pf R-TPR-004 in
    patients undergoing treatment for
    acute ischemic stroke vide protocol
    No. RLS/TP/2010/03, version 2.0
    dated 03/10/2012”
    2 4-126/CADILA/12-BD Cadila Healthcare Rituximab "A randomized controlled study to 21-Mar-13
    Ltd evaluate pharmacokinetic,
    pharmacodynamics (efficacy) and
    safety of Rituximab (Zydus) and
    Rituximab (Roche) in patients with
    Rheumatoid Arthritis" vide Protocol
    No. RIT.11.001.01, version 1.1 dated
    06/11/2012
    3 4-164/Quintiles/12-BD Quintiles Phase egfilgrastim "Pharmacokinetic and 16-Apr-13
    One Clinical Pharmacodynamic Bioequivalence of
    Trials pvt. Ltd. Single Dose Zydus Pegfilgrastim to
    Neulasta Pegfilgrastim from US and
    EU source" vide protocol No. QHYD -
    0001, Version 1.0 dated 31/05/2012
    4 4-154/Mabpharm/12-BD Mabpharma Pvt Pegfilgrastim "An Open-label, multi-centric, parallel 17-Apr-13
    Ltd group, comparative, randomized study
    to compare the safety and efficacy of
    Trastuzumab power for soluction for
    infusion manufactured by Mabpharm
    Pvt. Ltd.,withHerception of Roche Ltd.,
    UK in patients with HER2
    overexpressing metastatic breast
    cancer" vide Protocol No.
    MAB/01/2011,version 03, dated
    25/06/2013
    4-112/RELIANCE/11-BD Reliance Life Pegfilgrastim A randomized, balanced, open-label, 8-May-13
    Science Pvt. Ltd two-treatment, two sequence, two-
    5 period, single subcutaneous dose,
    crossover stidy to compare the

    Page 1 of 2
    Permission given for clinical trial (r-DNA based Drug Product) (2013)

    pharmacokinetics/pharmacodynamics
    (PK/PD) of test R-TPR-029
    (Pegfilgrastim 6mg/0.6ml) of Reliance
    Life Sciences Pvt. Ltd., India with
    reference Neulasta (Neulastim)
    Pegfilgrastim 6mg/0.6ml of Amgen
    Ltd." vide Protocol No. RC/0812/039,
    version 3.0 dated 20/12/ 2012-reg.
    6 4-175/Hetero/12-BD Hetro Rituximab "A randomized, multi-dose, 14-may 13
    multicente, comparative parallel study
    to evaluate the efficacy, safety and
    pharmacokinetic charactteristics of
    Intravenous infusion of Rituximab
    (Hetero) and Reference Medicial
    Product (Rituximab, Roche) In indian
    Patients of Non-Hodgkin's Lymphoma
    (HERILY study)"vide Protocol No.
    HCR/III/Ritux/06/2012, Version 1.1
    dated01/11/2012
    7 4-135/symmetrix /12-BD M/s Symmetrix smrx-11 “Efficacy and safety of bolus injection 19-Dec
    Biotech Private of a novel thrombolytic agent (smrx- 2013
    Limited 11) in patients with acute st-segment
    elevation myocardial infarction STEMI
    A phase II open label dose escalation
    multi centre angiographic trial” vide
    protocol no .13-vin-287 (cssksmrx-11)
    version D02, dated 17/07/2013

    Page 2 of 2

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