FDA approves the Human Food Safety Dossier
Brisbane, Feb 5, 2018 AEST (ABN Newswire) - Anatara Lifesciences (
ASX:ANR) has achieved a significant milestone in the United States of America after receiving a "complete" letter from the US Food and Drug Administration (FDA) for the Technical Section of its Human Food Safety (HFS) submission. The HFS is a major component of a New Animal Drug Application (NADA) which is currently underway and is necessary for enabling the marketing of Detach(R) in the US.
Key points:
- Significant milestone achieved in the United States with the receipt of a "complete" letter for the technical section of the human food safety submission for Detach(R)
- Letter confirms that the US Food and Drug Administration is satisfied that food products from animals treated using Detach(R) will be safe for human consumption
- Human food safety dossier forms one part of the application required to register Detach(R) for sale in the United States; approved ahead of time expectations
The complete letter confirms that the FDA's Office of New Animal Drug Evaluation, Center for Veterinary Medicine, is satisfied that the human food safety requirements for Detach(R) have been met and that food products from animals treated using Detach(R) are considered safe for human consumption.
The HFS Technical Section includes an assessment as to whether Detach(R) will contribute to antimicrobial resistance (drug resistance).
Anatara's Chairman and CEO, Dr Mel Bridges commented, "Safety of edible products from drug-treated, food-producing animals is a critical part of the US drug approval process, so receipt of the complete letter is a core step for the entry of Detach(R) into world markets.
The efficacy, overall safety and manufacturing information required for the approval of human and animal drugs is very similar, but the safety of a drug targeted at food-producing animals must undergo an additional level of stringent review to ensure that there are no residual safety issues for the human consumer.
The Human Food Safety section of the registration process can alone take from three to six years to complete, and can represent 50 to 70 percent (or between $5 to $8 million) of expenditure for a new drug (see Note below). The fact that Anatara has achieved an outcome within three years of opening our Investigational New Animal Drug application is an outstanding result and speaks to the strong safety profile we've seen for Detach(R) in our trials.
Registering Detach(R) in the US will be key to the safe sale of the product in that market for Antara or a commercial partner."
Note: Committee on Drug Use in Food Animals, Panel on Animal Health, Food Safety, and Public Health, National Research Council, 1999. The Use of Drugs in Food Animals: Benefits and Risks. ISBN: 0-309-52536-5
About Anatara Lifesciences Limited
Anatara Lifesciences Limited (ASX:ANR) is developing and commercialising innovative, evidence-based products for gastrointestinal health where there is significant unmet need. Anatara is a life sciences company with expertise in developing productsfor human and animal health. Anatara is focused on building a pipeline of human gastrointestinal health products. Underlying this product development program is our commitment to delivering real outcomes for patients and strong value for our shareholders.
| ||
|
