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    Alembic Pharmaceuticals gets USFDA nod for pain relief ointment -Xylocaine

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2018-11-27T13:19:48+05:30  |  Updated On 27 Nov 2018 1:19 PM IST
    Alembic Pharmaceuticals gets USFDA nod for pain relief ointment -Xylocaine

    NEW DELHI: Alembic Pharmaceuticals Monday said its joint venture Aleor Dermaceuticalshas received approval from the US health regulator for Xylocaine ointment, used for temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin and insect bites.


    "Aleor Dermaceuticals has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Lidocaine ointment USP, 5 per cent," Alembic Pharmaceuticals said in a BSE filing.

    Aleor is a 60:40 joint venture between Alembic and Orbicular Pharmaceutical Technologies Pvt Ltd (Orbicular) formed in Apr'16 focusing on commercialising dermatology products globally.

    The approved product is therapeutically equivalent to AstraZeneca Pharmaceuticals' Xylocaine ointment, 5 per cent.

    Quoting IQVIA data, Alembic Pharmaceuticals said Lidocaine ointment has an estimated market size of USD 97 million for twelve months ending December 2017.

    Alembic has a cumulative total of 79 ANDA approvals (66 final approvals and 13 tentative approvals) from USFDA, including this first ANDA approval for Aleor.

    Alembic Pharmaceuticals Limited, a vertically integrated research and development 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. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.

    Also Read: Alembic Pharma gets 4 observation by USFDA for Panelav facility
    AlembicaleorANDAapprovalIQVIAjoint ventureointmentpain reliefpharmapharmaceuticalUSFDAXylocaine
    Source : PTI

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    Medical Dialogues 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. Check out more about our bureau/team here

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