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    Glenmark gets tentative USFDA nod to breast cancer injection Fulvestrant

    Farhat NasimWritten by Farhat Nasim Published On 2019-02-08T11:40:41+05:30  |  Updated On 19 Dec 2022 6:02 PM IST
    Glenmark gets tentative USFDA nod to breast cancer injection Fulvestrant

    Fulvestrant injection is a generic version of AstraZeneca Pharmaceuticals LP's Faslodex injection in the same strength, it added. The Faslodex injection 250 mg/5 mL (50 mg/mL) brand and all available therapeutic equivalents achieved annual sales of around USD 533.3 million, Glenmark said.


    New Delhi: Mumbai based Glenmark Pharmaceuticals recently received tentative approval from the United States Food & Drug Administration (USFDA) for Fulvestrant injection used for the treatment of advanced breast cancer in postmenopausal women.


    Drug firm Glenmark Pharmaceuticals Thursday said it has received tentative approval from the US health regulator for generic Fulvestrant injection used for the treatment of advanced breast cancer in postmenopausal women.


    Glenmark Pharmaceuticals Inc, USA, has been granted tentative approval by the United States Food & Drug Administration (USFDA) for Fulvestrant injection, 250 mg/5 mL (50 mg/mL), the company said.


    The product is a generic version of AstraZeneca Pharmaceuticals LP's Faslodex injection in the same strength, it added. The Faslodex injection 250 mg/5 mL (50 mg/mL) brand and all available therapeutic equivalents achieved annual sales of around USD 533.3 million, Glenmark said.


    Read Also: Roche's Tecentriq gets instant FDA review in tough-to-treat breast cancer


    The company's current portfolio consists of 148 products authorised for distribution in the US market and 54 abbreviated new drug applications (ANDA's) pending approval with the USFDA.


    Fulvestrant, sold under the brand name Faslodex among others, is a medication used to treat hormone receptor (HR)-positive metastatic breast cancer in postmenopausal women with disease progression as well as HR-positive, HER2-negative advanced breast cancer in combination with palbociclib in women with disease progression after endocrine therapy.


    The injection is used for the treatment of hormone receptor positive, human epidermal growth factor receptor 2 - negative advanced breast cancer in postmenopausal women.


    Glenmark Pharmaceuticals is headquartered in Mumbai. The company was founded in 1977 by Gracias Saldanha as a generic drug and active pharmaceutical ingredient manufacturer.


    Read Also: Pfizer announces $3 million grant for ASPIRE Breast Cancer Research

    abbreviated new drug applicationsANDAsAstraZeneca Pharmaceuticalsbreast cancerBSEFaslodex injectiongenericgeneric Fulvestrant injectionGlenmarkGlenmark PharmaceuticalsInjectionNew DelhipostmenopausalShares of Glenmark Pharmaceuticalstentative nodtreatmentUnited States Food & Drug AdministrationUSUS health regulatorUSAUSFDA
    Source : With input

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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