Cipla's USA associate receives CRL from USFDA for IV Tramadol

The company is anticipating NDA re-submission in February 2021.

Dec 18, 2020 02:12 IST India Infoline News Service

Avenue Therapeutics, Inc., Cipla's step down associate company in USA, 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.

Cipla was trading at Rs793 per piece up by 1.25% or Rs9.80 from its previous closing on the BSE, at around 2:33pm.

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