USFDA

Crack GPAT — Prepare for GPAT Online 

  • AstraZeneca and its hematology research and development center of excellence, Acerta Pharma, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for acalabrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Acalabrutinib is an investigational, highly selective, potent Bruton tyrosine kinase (BTK) inhibitor in development for the treatment of multiple B-cell cancers.

  • Amgen announced that the U.S. Food and Drug Administration (FDA) has granted priority review for Amgen's supplemental Biologics License Application (sBLA) for Repatha® (evolocumab), a PCSK9 inhibitor. If approved by the FDA, the U.S. Prescribing Information for Repatha will be updated to include risk reduction of major cardiovascular events based on data from the large cardiovascular outcomes study (FOURIER). The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of Dec. 2, 2017.

  • 21 July 2017
    CRITICAL AND COMPARATIVE ANALYSIS OF ANDA FILLING OF TABLETS IN INDIA, EUROPE AND US

    { DOWNLOAD AS PDF }

    ABOUT AUTHORS
    Ms. NEETU*, Dr. ANUPAMA SETIA, Mr. MUNISH THAKUR
    *JCDM COLLEGE OF PHARMACY,
    SIRSA-HARYANA (INDIA)
    *neetu.kaushal11@gmail.com

    ABSTRACT
    Abbreviated New Drug Application (ANDA) is an application used for regulatory submission for the authorization of generics drugs and its entry into a brand drug market. Generic drugs are pharmaceutical equivalent to the brand name drugs and distributed without patent protection. Different countries have different requirements for the registration of generic drugs and its own regulatory authority, which are responsible to enforce the rules and regulations, issue the guidelines to regulate the marketing of drugs. Various government agencies in regulating drugs are CDSCO- India, EDQM-Europe, and USFDA-US. Aim of title was to review the generic drug filing and different aspect of obtaining regulatory approval in order to get the marketing authorization in India, Europe & US. Involvement of regulatory in the generic drug development expedites the approval process and they review the queries carefully raised by the regulatory authorities and minimize them. To harmonize the different requirements, CTD format is used for filing the ANDA in respective countries. In this an attempt was made to highlight the difference between the registration requirements for generics drugs in India, Europe & US. The comparison parameters in the generic drug approval among different regions, which gives clear illustration where India lies in its generic drug approval process.

  • The U.S. Food and Drug Administration approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis. Vosevi is a fixed-dose, combination tablet containing two previously approved drugs – sofosbuvir and velpatasvir – and a new drug, voxilaprevir. Vosevi is the first treatment approved for patients who have been previously treated with the direct-acting antiviral drug sofosbuvir or other drugs for HCV that inhibit a protein called NS5A.

  • Mylan N.V.and Biocon Ltd. announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the companies’ proposed biosimilar trastuzumab. The committee voted 16-0 in support of eligible indications of the reference product, Herceptin®, which include HER2-positive breast cancer in the metastatic and adjuvant settings.

  • Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture Sevelamer Carbonate oral suspension, 0.8 gm and 2.4 gm. Sevelamer Carbonate oral suspension, a therapeutic equivalent generic version of Genzyme's Renvela® oral suspension. The product is being launched immediately.

Subscribe to USFDA