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Therapeutic Area

Urea Cycle Disorders

Therapeutic area intelligence for Urea Cycle Disorders with 9 indexed intelligence signals across regulatory, clinical, competitive, and market developments.

Signals
9
Catalysts
0
Companies
5

Companies

Annora Pharma →
Aurobindo Pharma →
Esjay Pharma →
Lupin →
Teva →

Assets

Aurobindo →
FDA →
MEDUNIK →

Recent signals(9)

RegulatoryAugust 2, 2026

FDA Approves Glycerol Phenylbutyrate Application by Lupin

The FDA has approved the application ANDA207694 for Glycerol Phenylbutyrate submitted by Lupin.

RegulatoryAugust 1, 2026

FDA Grants Approval for Glycerol Phenylbutyrate by Esjay Pharma

The FDA has granted approval for the ANDA220579 application for Glycerol Phenylbutyrate submitted by Esjay Pharma.

RegulatoryJuly 29, 2026

FDA Grants Approval for Glycerol Phenylbutyrate by Navinta LLC

The FDA has granted approval for the ANDA220568 application for Glycerol Phenylbutyrate submitted by Navinta LLC.

RegulatoryJuly 27, 2026

Aurobindo Pharma's Glycerol Phenylbutyrate Receives FDA Submission Approval

Aurobindo Pharma has received FDA submission approval for Glycerol Phenylbutyrate under application ANDA220313.

RegulatoryJuly 27, 2026

FDA Grants Approval for Glycerol Phenylbutyrate (ANDA219540)

The FDA has granted approval for Glycerol Phenylbutyrate under application ANDA219540, submitted by MSN.

RegulatoryJuly 26, 2026

FDA Grants Approval for Glycerol Phenylbutyrate by Teva Pharmaceuticals

Teva Pharmaceuticals has received FDA approval for Glycerol Phenylbutyrate under application ANDA218738.

RegulatoryJuly 23, 2026

FDA Approves Supplement for PHEBURANE (NDA216513) by MEDUNIK

The FDA has approved a supplemental application for PHEBURANE, a treatment containing sodium phenylbutyrate.

RegulatoryJuly 20, 2026

FDA Grants Approval for L-Glutamine ANDA219722 by Annora Pharma

The FDA has granted approval for Annora Pharma's ANDA219722 for L-Glutamine.

RegulatoryJuly 4, 2026

Aurobindo Pharma's Glycerol Phenylbutyrate Application Receives FDA Review

Aurobindo Pharma has submitted an original application for Glycerol Phenylbutyrate under ANDA220313, which is currently under standard review by the FDA.

Upcoming catalysts

No catalysts indexed for this entity yet.

Indications

Metabolic Disorders →
Rare Diseases →
Urea Cycle Disorders →

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