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    Alembic Pharma gets USFDA approval for Olopatadine Hydrochloride Ophthalmic Solution

    Farhat NasimWritten by Farhat Nasim   |  

    Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% is indicated for the treatment of ocular itching associated with allergic conjunctivitis.


    New Delhi: Alembic Pharmaceuticals Limited today announced that the Company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2%.


    Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% is indicated for the treatment of ocular itching associated with allergic conjunctivitis.




    Conjunctivitis is usually associated with redness of the white part of the eyes, light sensitivity (photophobia), excessive tearing, ocular discomfort (gritty sensation, itching, burning), and/or discharge. There are many different causes of conjunctivitis.


    The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Pataday Ophthalmic Solution, 0.2%, of Novartis Pharmaceuticals Corporation.


    Also Read: Alembic Pharma gets USFDA nod toTeriflunomide tablets, Tobramycin ophthalmic solution


    Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% have an estimated market size of US$ 62 million for twelve months ending December 2018 according to IQVIA. Alembic now has a total of 93 ANDA approvals (81 final approvals and 12 tentative approvals) from USFDA.


    Alembic Pharmaceuticals Limited, vertically integrated research and development the pharmaceutical company has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.


    Also Read: Alembic Pharma receives USFDA nod for Bimatoprost Ophthalmic Solution

    Alembic PharmaAlembic PharmaceuticalsANDAconjunctivitisIQVIANovartisocular itchingolopatadine hydrochlorideOlopatadine Hydrochloride Ophthalmic Solution USPpataday ophthalmicPataday Ophthalmic Solutionspharmapharma newsred eyesUSFDA

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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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