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VEINAMINE 8%

NDA

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE | N017957 | HOSPIRA INC

4 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from B. Braun Medical Inc. FDA-2006-P-0534 · 6 docket documents B. Braun Medical Inc. filed this petition on September 29, 2006, requesting that the FDA determine whether B. Braun Medical can file an ANDA for a 15% amino acid solution using Novamine 15% (NDA 17-957), manufactured by Hospira, as the referenced listed drug, despite Novamine 15% not being designate	505(q)	2008-08-05	Withdrawn	B. Braun Medical Inc.
B. Braun Medical, Inc. - CItizen Petition FDA-2007-P-0241 · 4 docket documents B. Braun Medical Inc. filed this suitability petition under 21 CFR 314.93 and Section 505(j)(2)(c) requesting that the FDA determine it is suitable for the company to package its 15% Amino Acid Injection in a 1L glass bottle, a package size not covered by the reference listed drug Novamine (manufact	Other	2008-05-19	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

21 trials from ClinicalTrials.gov — 1 recruiting, 12 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pilot Study of BCAA on Sleep NCT03990909	N/A	Recruiting	Portland VA Medical Center	300	2019-03-01 → 2025-12-01
Modulation of Systemic Inflammatory Response in Critically Ill Children After Glutamine Supplementation NCT01367223	Phase 4	Completed	Hospital Sant Joan de Deu	101	2010-04 → 2013-05
Vitamin B6 Dependence of One-Carbon Metabolism NCT00877812	N/A	Completed	University of Florida	45	2008-01 → 2010-09
Nutrition Supplementation in Hospitalized Patients NCT02632630	Phase 2	Completed	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	100	2016-03 → 2018-02
Effect of Intravenous Nutrition and Epidural Analgesia on Protein Loss After Surgery NCT00614133	N/A	Completed	McGill University Health Centre/Research Institute of the McGill University Health Centre	22	2004-06 → 2007-06
Characterizing the Incretin Effect of Amino Acids and Defining GLP-1 Role on Skeletal Muscle NCT02370745	N/A	Completed	University of Nottingham	40	2014-11 → 2018-03
Can Amino Acid Supplementation Augment the Anabolic Response in Tendon After Exercise NCT04067479	N/A	Completed	Purdue University	7	2017-05-09 → 2022-12-20
Metabolic Effects of Chemical Interactions in Toxicity NCT00253773	N/A	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	15	2005-01 → 2007-11
Diagnosis of Covert/Minimal Hepatic Encephalopathy by Means of Continuous Reaction Time Measurement NCT01773538	N/A	Completed	Mette Munk Lauridsen	136	2013-01 → 2015-11
Effect of Obesity-derived Cytokines on Protein Turnover and Carbohydrate Metabolism in Human Skeletal Muscle NCT02305069	N/A	Completed	University of Nottingham	26	2009-10 → 2012-09

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jan 13, 2005	SUPPL -39	View Letter (PDF)
May 29, 2003	SUPPL -32	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

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#003 — 11.4% (11.4GM/100ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Aug 9, 1982

#004 — 15% (75GM/500ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Nov 28, 1986

#002 — 8.5% (8.5GM/100ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Aug 9, 1982

#001 — 8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/100ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.