SEBI Reg. Investment Advisor

Download App

MoneyWorks4Me

Cipla’s US arm gets complete response letter from USFDA for IV Tramadol

13 Oct 2020 Evaluate

Cipla’s step-down US-based subsidiary -- Avenue Therapeutics, Inc has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (USFDA) regarding the Company’s New Drug Application (NDA) for IV tramadol.

The CRL stated that although the pivotal Phase 3 clinical trials demonstrated statistically significant outcomes for all of the primary and many secondary endpoints, the FDA has determined that it cannot approve the application in its present form. The CRL stated that IV tramadol, intended to treat patients in acute pain who require an opioid, is not safe for the intended patient population. Specifically, if a patient requires an analgesic between the first dose of IV tramadol and the onset of analgesia, a rescue analgesic would be needed. The likely choice would be another opioid, which would result in opioid stacking and increase the likelihood of opioid-related adverse effects. Other than this potential safety concern, the FDA did not identify a safety signal in Avenue’s clinical development program. In addition, the CRL stated that the FDA requires an adequate terminal sterilization validation prior to NDA approval, which is planned for later this quarter.

Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients.

Cipla Share Price

1365.25 31.70 (2.38%)
06-May-2026 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1850.40
Dr. Reddys Lab 1310.50
Cipla 1365.25
Zydus Lifesciences 939.10
Lupin 2442.35
View more..

About MoneyWorks4Me

MoneyWorks4Me is a SEBI-registered Investment Adviser (IA) dedicated to helping investors build long-term wealth through transparent, research-driven, conflict-free guidance. Founded in 2008, we started our journey as a Research Analyst (RA), providing deep fundamental analysis, intrinsic value insights, and long-term investing frameworks for Indian equities. In 2017, we transitioned to a full-fledged SEBI-registered Investment Adviser, strengthening our commitment to acting as a fiduciary—always putting the investor’s interest first.

Our Vision

To become India’s most trusted, research-powered fiduciary advisory platform—where every investor, regardless of experience, can make calm, confident, and well-reasoned investment decisions.

What Makes MoneyWorks4Me Different

Our Approach: Ensuring compounding work its magic on client portfolio.

MoneyWorks4Me ensures this through:

×