Alembic Generic Fingolimod Hydrochloride 0.5mg Capsule Approved
Summary
The FDA approved Alembic Pharmaceuticals' Abbreviated New Drug Application (ANDA 207974) for Fingolimod Hydrochloride 0.5mg oral capsules on April 24, 2026. The generic drug carries a therapeutic equivalence (TE) code of AB, indicating it is bioequivalent to the reference listed drug Gilenya by Novartis. Fingolimod is used to treat patients with relapsing forms of multiple sclerosis.
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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 — 17 changes logged to date.
What changed
The FDA granted approval to Alembic Pharmaceuticals for ANDA 207974, authorizing the marketing of Fingolimod Hydrochloride 0.5mg capsules as a generic version of Novartis' Gilenya. The approval classifies the drug as AB-rated (bioequivalent) with prescription marketing status. Generic manufacturers and their distribution partners should update their product catalogs to reflect this newly available AB-rated alternative for fingolimod, which may affect pricing negotiations and formulary positioning in the MS treatment market.
Archived snapshot
Apr 28, 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): 207974
Company: ALEMBIC
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| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 04/24/2026 | ORIG-1 | Approval | STANDARD | Label is not available on this site. |
FINGOLIMOD HYDROCHLORIDE
CAPSULE;ORAL; EQ 0.5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207991 | ACCORD HLTHCARE |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207974 | ALEMBIC |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208004 | ALKEM LABS LTD |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207993 | APOTEX |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207983 | AUROBINDO PHARMA LTD |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207979 | BIOCON LTD |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210252 | BIONPHARMA |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208000 | DR REDDYS |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207945 | EZRA VENTURES |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207985 | GLENMARK PHARMS LTD |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207939 | HEC PHARM CO LTD |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207933 | HETERO LABS LTD V |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208003 | PRINSTON INC |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208008 | TEVA PHARMS USA |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207994 | ZYDUS PHARMS |
| GILENYA | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 022527 | NOVARTIS |
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