Alembic Pharma gets USFDA nod for insomnia treatment drug

New Delhi: Drug firm Alembic Pharmaceuticals has received approval from the US health regulator for Temazepam capsules, used for treatment of insomnia.

The company has got approval from the US Food and Drug Administration (USFDA) to market the drug in the strength of 7.5mg, 15mg, 22.5mg and 40mg, Alembic Pharmaceuticals said in a BSE filing.

The approved abbreviated new drug application (ANDA) is the therapeutic equivalent to the reference listed drug product (RLD) Restoril Capsules.

Quoting IQVIA sales data, the company said, Temazepam capsules 7.5mg, 15mg, 22.5mg and 40mg had an estimated market size of USD 48 million for 12 months, ending December 2017.

The company’s stock was trading at Rs 567 apiece, up 1.33 per cent, on the BSE.

  • Related Posts

    ED attaches assets, freezes bank account in counterfeit medicines racket; searches five premises in Bengaluru

    During the raid, the accused were allegedly found storing medicines and pharmaceutical drugs without valid licences, permits or authorisations and replacing labels on the stored medicines. The Directorate of Enforcement…

    Hyderabad Startup Working On Personalised Cancer Vaccine: What It Means For Cancer Treatment

    Hyderabad startup PopVax develops personalised cancer vaccines using AI, machine learning, and mRNA tech to target unique tumour mutations. Cancer treatment is increasingly moving towards personalised approaches that take into…

    Leave a Reply

    Your email address will not be published.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

    You Missed

    ED attaches assets, freezes bank account in counterfeit medicines racket; searches five premises in Bengaluru

    ED attaches assets, freezes bank account in counterfeit medicines racket; searches five premises in Bengaluru

    Hyderabad Startup Working On Personalised Cancer Vaccine: What It Means For Cancer Treatment

    Hyderabad Startup Working On Personalised Cancer Vaccine: What It Means For Cancer Treatment

    Medicines that cure Us are making Our Environment Sick

    Medicines that cure Us are making Our Environment Sick

    ZEN- G packs a punch in Organ Donation as Over 500 Students pledge Organs

    ZEN- G packs a punch in Organ Donation as Over 500 Students pledge Organs

    PGIMS recalls drug amid probe into deaths

    PGIMS recalls drug amid probe into deaths

    NPPA list brings little relief: No price cut for 25% cancer drugs

    NPPA list brings little relief: No price cut for 25% cancer drugs