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An IVIVC system to facilitate the development of a generic Vitrasert

Award Number: U01FD004927
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2013
PERIOD OF PERFORMANCE END DATE: 09/30/2015

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An IVIVC system to facilitate the development of a generic Vitrasert - Project Summary The broad long term goal of this project is to develop an in vivo - in vitro correlation method (IVIVC) that can be applied to the assessments of intravitreal sustained release implants. Understanding IVIVC will greatly assist the FDA and the pharmaceutical industry in development and approval of generic and bioequivalent products. A secondary goal of this project is the development of a bioequivalent sustained release ganciclovir intravitreal implant to fill an unmet orphan medical need. For commercial reasons the Vitrasert has been removed from the market and is unlikely to be otherwise replaced. We propose a development strategy to make this therapeutic modality available to the small number of patients for whom it is the treatment of choice. The Vitrasert(R) was invented in the academic laboratory of the principal investigator of this proposal in 1989. In 1995 in collaboration with Chiron it was approved under NDA 020569. We believe that we are uniquely qualified to carry out this project.


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: 2017 ( Subtotal = $0 )
2017	2013	AURITEC PHARMACEUTICALS INC	3200 SANTA MONICA BLVD STE 201	SANTA MONICA	CA	90404	LOS ANGELES	USA	Food and Drug Administration Research	000	1	6/27/2017	NEW	$0
														Subtotal = $0

Issue Date FY: 2014 ( Subtotal = $0 )
2014	2013	AURITEC PHARMACEUTICALS LLC	15 BRAEBURN ROAD	HYDE PARK	MA	02136	SUFFOLK	USA	Food and Drug Administration Research	000	1	7/15/2014	NEW	$0
														Subtotal = $0

Issue Date FY: 2013 ( Subtotal = $499,280 )
2013	2013	AURITEC PHARMACEUTICALS LLC	15 BRAEBURN ROAD	HYDE PARK	MA	02136	SUFFOLK	USA	Food and Drug Administration Research	000	1	9/10/2013	NEW	$499,280
2013	2013	AURITEC PHARMACEUTICALS LLC	15 BRAEBURN ROAD	HYDE PARK	MA	02136	SUFFOLK	USA	Food and Drug Administration Research	002	1	9/13/2013	NEW	$499,280
2013	2013	AURITEC PHARMACEUTICALS LLC	15 BRAEBURN ROAD	HYDE PARK	MA	02136	SUFFOLK	USA	Food and Drug Administration Research	001	1	9/12/2013	NEW	-$499,280
														Subtotal = $499,280

Grand Total All Awards = $499,280

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An IVIVC system to facilitate the development of a generic Vitrasert

Award Number: U01FD004927

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/15/2013

PERIOD OF PERFORMANCE END DATE: 09/30/2015

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