Meridian reports positive pre-IND meeting with FDA for ML061

Published on January 29, 2013 at 1:08 AM · No Comments

Buffalo Grove, Illinois-based specialty-oncology drug development company, Meridian Laboratories, Inc (Meridian) held a Type B Pre-Investigational New Drug (pre-IND) meeting with the FDA Center for Drug Evaluation Research, Division of Oncology Products on Wednesday January 23, 2013 to discuss its plan to commence clinical development of ML061, Meridian's lead product, as a treatment for various types of cancer.

During the meeting, the FDA representatives and Meridian team discussed the proposed regulatory and clinical strategy for Meridian's ML061 program.  ML061 is an IP-protected reformulation of Taxotere that eliminates Polysorbate-80, an established allergan, and could, therefore, have an improved safety profile.  Meridian intends to seek approval with a New Drug Application in the United States under SEC.505(b)(2) [21 USC §355] New Drugs.

"We received positive feedback from the FDA.  FDA confirmed that, based on the information Meridian provided, the nonclinical data appeared appropriate to support the proposed bioequivalence study and that the 505(b)(2) regulatory path would be an acceptable approach," said William Zhao PhD, Chairman of Meridian.  

Steven Geis , PhD MD and George Allen Hides , who comprise Meridian's clinical team, attended the pre-IND meeting were gratified by FDA's preliminary confirmation of Meridian's strategic approach and are leading the effort to submit an IND to FDA.

Source:

Meridian Laboratories, Inc.

Posted in: Medical Condition News | Pharmaceutical News

Tags: , , , , , , ,

Read in | English | Español | Français | Deutsch | Português | Italiano | 日本語 | 한국어 | 简体中文 | 繁體中文 | Nederlands | Русский | Svenska | Polski
Comments
The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News-Medical.Net.
Post a new comment
Post
You might also like... ×
Taiho Oncology presents TAS-102 Phase III RECOURSE trial results in mCRC patients