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    Alembic Pharma gets USFDA nod for Olopatadine Hydrochloride ophthalmic solution

    Farhat NasimWritten by Farhat Nasim Published On 2019-02-17T09:30:28+05:30  |  Updated On 14 Aug 2021 12:23 PM IST

    The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Olopatadine Hydrochloride ophthalmic solution USP, 0.1 per cent, Alembic Pharmaceuticals said in a filing to BSE.


    New Delhi: Drug firm Alembic Pharmaceuticals Monday said it has received approval from the US health regulator for olopatadine hydrochloride ophthalmic solution, used to treat allergic conjunctivitis.


    The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Olopatadine Hydrochloride ophthalmic solution USP, 0.1 per cent, Alembic Pharmaceuticals said in a filing to BSE.


    Read Also: Alembic Pharma gets USFDA nod for Pramipexole Dihydrochloride extended-release tablets


    The approved product is therapeutically equivalent to the reference listed drug product (RLD) Patanol ophthalmic solution, 0.1 per cent, of Novartis Pharmaceuticals Corporation, the company added.


    Quoting IQVIA data, Alembic Pharma said Olopatadine Hydrochloride ophthalmic solution has an estimated market size of USD 61 million for 12 months ending December 2017.


    Read Also: Alembic Pharma gets USFDA nod for Olopatadine Hydrochloride ophthalmic solution


    The company said it currently has 83 ANDA approvals from USFDA.


    Read Also: Alembic Pharma gets USFDA nod for Candesartan Cilexetil tablets

    Abbreviated New Drug ApplicationAlembic PharmaAlembic Pharmaceuticalsallergic conjunctivitisANDABSEindian pharma newsIQVIA dataNew DelhiNovartis Pharmaceuticals CorporationOlopatadineolopatadine hydrochloride ophthalmic solutionOphthalmic solutionPatanol ophthalmic solutionpharmapharma newspharma news indiaShares of Alembic PharmaceuticalstreatUS Food and Drug AdministrationUS healthUSFDA
    Source : PTI

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    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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