Natco Pharma seeks USFDA approval for hepatitis drug

New Delhi: Drug firm Natco Pharma today said it has filed an abbreviated new drug application (ANDA) for Sofosbuvir Tablets, 400mg, with the United States Food and Drug Administration (USFDA).

Sofosbuvir is used for chronic hepatitis C infection and sold globally by Gilead Sciences, Inc, under its brand Sovaldi, Natco Pharma said in a filing to BSE.

The company believes that “they are the first to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity upon receiving final FDA approval,” it added.

For the 12 months ending December 31, 2017, Sovaldi had US sales of approximately USD 130 million as per Gilead Sciences Inc’s unaudited results released for the year ending December 31, 2017, Natco Pharma said.

Shares of Natco Pharma were trading at Rs 786.05 per scrip on BSE, down 1.65 per cent from its previous close.

  • Related Posts

    • Pharma
    • June 20, 2025
    • 144 views
    Key supplier in alprazolam smuggling racket arrested in Uttar Pradesh

    The prime accused in a racket involving the unauthorised sale of alprazolam tablets across Andhra Pradesh and Telangana was traced to Kanpur, Uttar Pradesh by the Telangana Prohibition and Excise…

    • Pharma
    • June 20, 2025
    • 124 views
    Cough Syrup Smuggling Ring Busted in Bihar’s Samastipur; Two Women Among Seven Arrested

    Samastipur:  Police in the district have arrested seven individuals, including two women, for allegedly smuggling nearly 1,000 bottles of banned cough syrup containing narcotic substances. The seizure, made during a…

    Leave a Reply

    Your email address will not be published.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

    You Missed

    Key supplier in alprazolam smuggling racket arrested in Uttar Pradesh

    Key supplier in alprazolam smuggling racket arrested in Uttar Pradesh

    Cough Syrup Smuggling Ring Busted in Bihar’s Samastipur; Two Women Among Seven Arrested

    Cough Syrup Smuggling Ring Busted in Bihar’s Samastipur; Two Women Among Seven Arrested

    Counterfeit cholesterol drugs worth Rs 3 lakh seized in raids at Koti

    Counterfeit cholesterol drugs worth Rs 3 lakh seized in raids at Koti

    Pharma stock jumps after receiving approval from UK’s MHRA to sell new pharma product

    Pharma stock jumps after receiving approval from UK’s MHRA to sell new pharma product