Avenue Therapeutics Provides Regulatory Update for IV Tramadol

Avenue Therapeutics, Inc. (NASDAQ: ATXI) (Avenue), a company focused on the development of intravenous (IV) tramadol for the U.S. market, today provided a regulatory update following receipt of the official meeting minutes from a November 2020 Type A meeting with the U.S. Food and Drug Administration (FDA) relating to a path forward for IV tramadol.

Avenue had requested this Type A meeting to address a Complete Response Letter (CRL) it received from the FDA regarding the New Drug Application (NDA) for IV tramadol. Avenue intends to resubmit the NDA in February 2021, barring any Covid-19 related or other setbacks. The NDA resubmission will incorporate revised language relating to the proposed product label and a report relating to terminal sterilization validation.

Shares of CIPLA LTD. was last trading in BSE at Rs.783.2 as compared to the previous close of Rs. 786.65. The total number of shares traded during the day was 139468 in over 2528 trades.

The stock hit an intraday high of Rs. 795 and intraday low of 781.55. The net turnover during the day was Rs. 109906002.

Source : Equity Bulls

Keywords