Alembic Pharmaceuticals gets USFDA nod for ophthalmic solution

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.

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.

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

Shares of Alembic Pharmaceuticals were trading 0.07 per cent lower at Rs 614 apiece on BSE.

  • Related Posts

    • Pharma
    • July 8, 2025
    • 69 views
    HC-ordered expert panel for weight loss drug may be set up by mid-July

    The Central Drugs Standard Control Organization (CDSCO) is likely to begin work on forming a court-ordered expert panel to study the unregulated use of weight loss drugs by mid-July, according…

    • Pharma
    • July 8, 2025
    • 39 views
    Biocon Biologics Gets UK Nod for Vevzuo, Evfraxy

    New Delhi: Biocon Ltd on Monday said its arm Biocon Biologics Ltd has received marketing authorisations from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for Vevzuo…

    Leave a Reply

    Your email address will not be published. Required fields are marked *

    You Missed

    HC-ordered expert panel for weight loss drug may be set up by mid-July

    HC-ordered expert panel for weight loss drug may be set up by mid-July

    Biocon Biologics Gets UK Nod for Vevzuo, Evfraxy

    Biocon Biologics Gets UK Nod for Vevzuo, Evfraxy

    Indian Medical Association opposes decision to allow homeopaths to prescribe modern medicines post pharma course

    Indian Medical Association opposes decision to allow homeopaths to prescribe modern medicines post pharma course

    ‘AACI Came, AACI Saw, AACI Conquered’ Indian Accreditation Domain in Healthcare

    ‘AACI Came, AACI Saw, AACI Conquered’ Indian Accreditation Domain in Healthcare