Cipla associate Avenue Therapeutics gets regulatory update for intravenous tramadol
Cipla said Avenue had requested this Type A meeting to address a CRL it received from the US health regulator regarding the New Drug Application (NDA) for IV tramadol. Avenue intends to resubmit the NDA in February 2021, barring any COVID19 related or other setbacks.
New Delhi: Drug major Cipla on Friday said its step-down associate company Avenue Therapeutics has received an update from the US health regulator for its new drug application for intravenous (IV) tramadol.
Avenue Therapeutics'' IV tramadol is intended to treat patients in acute pain who require an opioid.
"Avenue Therapeutics, Inc., a company focused on the development of IV tramadol for the US market, today provided a regulatory update following receipt of the official meeting minutes from a November 2020 Type A meeting with the US Food and Drug Administration (USFDA) relating to a path forward for IV tramadol," Cipla said in a regulatory filing.
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In October this year, Avenue Therapeutics Inc had received a complete response letter (CRL) from the USFDA which stated that the regulator has determined that it cannot approve the application for IV tramadol in its present form.
Cipla said Avenue had requested this Type A meeting to address a CRL it received from the US health regulator 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.
Cipla said the NDA re-submission will incorporate revised language relating to the proposed product label and a report relating to terminal sterilisation.
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