Glycerol Phenylbutyrate ANDA 220568 Approved for Navinta LLC
Summary
FDA approved Abbreviated New Drug Application (ANDA) 220568 for Glycerol Phenylbutyrate 1.1GM/ML oral liquid submitted by Navinta LLC on April 23, 2026. The drug received TE Code AA (therapeutic equivalence to reference listed drug), indicating it meets FDA standards for generic substitution. This approval adds a fifth generic manufacturer for this urea cycle disorder treatment, joining Aurobindo Pharma, MSN, PH Health, and Teva Pharma.
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GovPing monitors FDA Drugs@FDA - New Applications and Actions for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 14 changes logged to date.
What changed
FDA granted approval to Navinta LLC for ANDA 220568 covering Glycerol Phenylbutyrate oral liquid at 1.1GM/ML strength. The application received standard review priority with no orphan status designation. The approval grants Prescription marketing status under TE Code AA (therapeutic equivalence), meaning the generic is substitutable for the reference listed drug Ravicti manufactured by Horizon Therapeutics.
Generic drug manufacturers producing or marketing Glycerol Phenylbutyrate formulations should note this additional market entrant. Healthcare providers and pharmacists may consider therapeutic equivalence options when prescribing or dispensing. The approval expands the pool of available generics for this ammonia detoxifying agent used in urea cycle disorder management.
Archived snapshot
Apr 27, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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Abbreviated New Drug Application (ANDA): 220568
Company: NAVINTA LLC
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| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GLYCEROL PHENYLBUTYRATE | GLYCEROL PHENYLBUTYRATE | 1.1GM/ML | LIQUID;ORAL | Prescription | AA | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/23/2026 | ORIG-1 | Approval | STANDARD | Label is not available on this site. |
GLYCEROL PHENYLBUTYRATE
LIQUID;ORAL; 1.1GM/ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GLYCEROL PHENYLBUTYRATE | GLYCEROL PHENYLBUTYRATE | 1.1GM/ML | LIQUID;ORAL | Prescription | No | AA | 220313 | AUROBINDO PHARMA |
| GLYCEROL PHENYLBUTYRATE | GLYCEROL PHENYLBUTYRATE | 1.1GM/ML | LIQUID;ORAL | Prescription | No | AA | 219540 | MSN |
| GLYCEROL PHENYLBUTYRATE | GLYCEROL PHENYLBUTYRATE | 1.1GM/ML | LIQUID;ORAL | Prescription | No | AA | 220568 | NAVINTA LLC |
| GLYCEROL PHENYLBUTYRATE | GLYCEROL PHENYLBUTYRATE | 1.1GM/ML | LIQUID;ORAL | Prescription | No | AA | 205742 | PH HEALTH |
| GLYCEROL PHENYLBUTYRATE | GLYCEROL PHENYLBUTYRATE | 1.1GM/ML | LIQUID;ORAL | Prescription | No | AA | 218738 | TEVA PHARMS INC |
| RAVICTI | GLYCEROL PHENYLBUTYRATE | 1.1GM/ML | LIQUID;ORAL | Prescription | Yes | AA | 203284 | HORIZON THERAP US |
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