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    • Alembic Pharma gets...

    Alembic Pharma gets USFDA nod toTeriflunomide tablets, Tobramycin ophthalmic solution

    Farhat NasimWritten by Farhat Nasim Published On 2019-04-22T11:55:05+05:30  |  Updated On 16 Aug 2021 4:22 PM IST

    Teriflunomide tablets are indicated for the treatment of patients with relapsing forms of multiple sclerosis while Tobramycin ophthalmic solution is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria.


    New Delhi: Drug firm Alembic Pharmaceuticals Monday said it has received approvals from the US health regulator for its Teriflunomide tablets and Tobramycin ophthalmic solution. The company has received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Teriflunomide tablets in the strengths of 7 mg and 14 mg, Alembic Pharmaceuticals said in a filing to BSE.


    The product is a generic version of Sanofi-Aventis US LLC's Aubagio tablets in the same strengths, it added.


    According to IQVIA, teriflunomide tablets, 7 mg and 14 mg have an estimated market size of USD 1.6 billion for 12 months ending December 2018, Alembic Pharma said.


    Teriflunomide tablets are indicated for the treatment of patients with relapsing forms of multiple sclerosis, Alembic Pharma said.


    The company has also received approval from the USFDA for its ANDA for Tobramycin ophthalmic solution USP, 0.3 per cent, it added.


    The product is a generic version of Novartis Pharmaceuticals Corporation's Tobrex ophthalmic solution in the same strength, Alembic Pharma said.


    Citing IQVIA, the company said tobramycin ophthalmic solution USP, 0.3 per cent have an estimated market size of USD 9.6 million for twelve months ending December 2018.


    The product is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria, Alembic Pharma said.


    The company now has a total of 92 ANDA approvals (80 final approvals and 12 tentative approvals) from USFDA, it added.


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

    adnexaAlembic PharmaAlembic PharmaceuticalsantibioticsAubagio Tabletseye infectiongenericIQVIAmultiple sclerosisNovartisSanofiTeriflunomideTeriflunomide tabletsTobramycintobramycin ophthalmic solutionTobrexTopical medicationUSFDA
    Source : PTI

    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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