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    Alembic Pharma gets USFDA nod for spasticity drug Tizanidine

    MD bureauWritten by MD bureau Published On 2020-01-15T10:15:19+05:30  |  Updated On 15 Jan 2020 5:47 PM IST
    Alembic Pharma gets USFDA nod for spasticity drug Tizanidine

    New Delhi: Drug firm Alembic Pharmaceuticals on Wednesday said it has received final nod from the US health regulator for Tizanidine hydrochloride capsules, used to treat spasticity.

    "The company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tizanidine Hydrochloride Capsules, 2 mg, 4 mg, and 6 mg," the drug firm said in a regulatory filing.


    Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity.


    Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important.


    "The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Zanaflex Capsules, 2 mg, 4 mg, and 6 mg, of Covis Pharma BV," the filing said.

    Tizanidine hydrochloride capsules, 2 mg, 4 mg, and 6 mg have an estimated market size of USD 28 million for twelve months ending September 2019 according to IQVIA.


    Alembic has a cumulative total of 111 ANDA approval -- 99 final approvals and 12 tentative approvals -- from USFDA.


    Also Read: Alembic Pharma International Formulations Grew 10pc To Rs 646 Crore In Q2

    Source : PTI

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    MD bureau
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      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in.

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