Cipla - FDA’s Second CRL To IV Tramadol Put A Death Nail On The Launch Of NDA In U.S.: Prabhudas Lilladher

BQ Blue’s special research section collates quality and in-depth equity and economy research reports from across India’s top brokerages, asset managers and research agencies. These reports offer BloombergQuint’s subscribers an opportunity to expand their understanding of companies, sectors and the economy.

Prabhudas Lilladher Report

While Cipla Ltd. guided to launch at least one specialty/limited competition drug in a quarter, its plan for first specialty product launch in U.S. received a setback post Food and Drug Administration’s second CRL (complete response letter) in IV Tramadol.

U.S. Food and Drug Administration issued second CRL on the new drug applicaiton of IV Tramadol, stated that

1. 'delayed and unpredictable onset of analgesia' quashes the claim of effective treatment of patients in acute pain and

2. Insufficient data to support its claim to be effective in combination therapy.

Click on the attachment to read the full report:

DISCLAIMER

This report is authored by an external party. BloombergQuint does not vouch for the accuracy of its contents nor is responsible for them in any way. The contents of this section do not constitute investment advice. For that you must always consult an expert based on your individual needs. The views expressed in the report are that of the author entity and do not represent the views of BloombergQuint.

Users have no license to copy, modify, or distribute the content without permission of the Original Owner.