Biocon gets USFDA nod for generic product

Biotechnology major Biocon on Thursday said its unit has received approval from the US health regulator to market a generic product.

Biocon Pharma, a subsidiary of the company, has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Mycophenolic Acid, the company said in a regulatory filing.

The product is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant and is available in 180mg and 360mg strengths.

This approval further adds to Biocon’s portfolio of vertically integrated complex drug products, the company noted.

  • Related Posts

    PGIMS recalls drug amid probe into deaths

    The PGIMS authorities have directed all departments to immediately stop using a specific batch of injectable Propofol, an anaesthetic drug, and return the available stock to the central store. The…

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

    Mumbai: Nearly one in four cancer drug packs in a revised price list issued by the National Pharmaceutical Pricing Authority (NPPA) has seen no reduction in maximum retail price (MRP),…

    Leave a Reply

    Your email address will not be published.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

    You Missed

    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

    Centre Mandates Minimum One-Year Shelf Life For Imported Drugs

    Centre Mandates Minimum One-Year Shelf Life For Imported Drugs

    For Aakash Healthcare, Community People are Apples of its Eyes

    For Aakash Healthcare, Community People are Apples of its Eyes

    Not mandatory to recall stocks released to the market prior to implementation of TMR: NPPA

    Not mandatory to recall stocks released to the market prior to implementation of TMR: NPPA

    Yashoda Medicity: Baby takes a Giant Step in just One Year

    Yashoda Medicity: Baby takes a Giant Step in just One Year