Tuesday, January 6, 2026 1/6/2026

Stability Study Protocol for 0.1% Estradiol Type A Medicated Article (Estraqua?)

Award Number: R01FD008458
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/20/2025
PERIOD OF PERFORMANCE END DATE: 08/31/2027

Group Awards By:

View Award Description

Stability Study Protocol for 0.1% Estradiol Type A Medicated Article (Estraqua?) - RESEARCH & RELATED Other Project Information: Section 7 Project Summary/Abstract This Type A stability project is required by the FDA Center for Veterinary Medicine to complete a portion of the CMC technical section of the new animal drug application. This project will evaluate stability of INAD 012-884 (Type A Medicated Article, 0.1% estradiol (Estraqua®)) under ambient (25 ± 2 °C / 60 ± 5% RH) and accelerated (40 ± 2 °C / 75 ± 5% RH) conditions over several months. Appearance, estradiol level, particle size distribution and loss upon drying will be evaluated over time. The proposed INAD will be administered in feed (at a dosing rate of 5 ppm) to American eels (Anguilla rostrata) in a recirculating aquaculture system (RAS). Information from this stability study will substantially contribute to full FDA approval.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2025	NOVAEEL INC	2161 ARMCRESCENT EAST DR	HALIFAX	NS			CAN	Food and Drug Administration Research	000	1	12/17/2025	NEW	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $250,000 )
2025	2025	NOVAEEL INC	2161 ARMCRESCENT EAST DR	HALIFAX	NS			CAN	Food and Drug Administration Research	000	1	9/19/2025	NEW	$250,000
														Subtotal = $250,000

Grand Total All Awards = $250,000

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Stability Study Protocol for 0.1% Estradiol Type A Medicated Article (Estraqua?)

Award Number: R01FD008458

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/20/2025

PERIOD OF PERFORMANCE END DATE: 08/31/2027

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer