Infantile Spasms
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-07-22EMA Authorised: Kigabeq (vigabatrin) — ORPHELIA Pharma
EMA has authorised Kigabeq (vigabatrin) for infantile spasms and partial epilepsies, with ORPHELIA Pharma as the marketing authorization hol…
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EMA approval · 2026-07-09EMA Authorised: Ztalmy (ganaxolone) — Marinus Pharmaceuticals Emerald Limited
Ztalmy (ganaxolone) has been authorised by the EMA for infantile spasms and related epileptic syndromes.
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EMA approval · 2026-07-01EMA Authorised: Ztalmy (ganaxolone) — Marinus Pharmaceuticals Emerald Limited
Ztalmy (ganaxolone) has been authorised by the EMA for epileptic syndromes and infantile spasms, with orphan designation.
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FDA approval · 2026-03-18FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)
The FDA approved a supplemental application for Sabril (vigabatrin) submitted by Lundbeck Pharmaceuticals LLC.
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FDA approval · 2026-03-18FDA Approved: VIGABATRIN — Supplemental Application (Novadoz Pharmaceuticals LLC)
The FDA approved a supplemental application for Vigabatrin submitted by Novadoz Pharmaceuticals LLC.
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FDA approval · 2026-03-18FDA Approved: VIGABATRIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for Vigabatrin by Amneal Pharmaceuticals NY LLC.
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FDA approval · 2026-03-18FDA Approved: VIGABATRIN — Supplemental Application (Dr. Reddys Laboratories Inc.,)
FDA approved a supplemental application for Vigabatrin filed by Dr. Reddys Laboratories Inc.
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FDA approval · 2026-03-18FDA Approved: VIGABATRIN — Supplemental Application (Cipla USA, Inc.)
The FDA approved Cipla USA, Inc.'s supplemental application for Vigabatrin, resulting in an approved change to the labeling for the product.…
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FDA approval · 2026-03-18FDA Approved: VIGABATRIN — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for Vigabatrin submitted by Zydus Lifesciences Limited. This action constitutes a supplemental appro…
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FDA approval · 2026-03-18FDA Approved: VIGABATRIN — Supplemental Application (Edenbridge Pharmaceuticals LLC.)
FDA approved a supplemental application for Vigabatrin submitted by Edenbridge Pharmaceuticals LLC, authorizing the marketing of the generic…
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FDA approval · 2026-03-18FDA Approved: VIGABATRIN — Supplemental Application (Hikma Pharmaceuticals USA Inc)
The FDA approved a supplemental application for Vigabatrin from Hikma Pharmaceuticals USA Inc., updating the drug's labeling.
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FDA approval · 2026-03-18FDA Approved: VIGABATRIN — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Vigabatrin submitted by Aurobindo Pharma Limited.
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FDA approval · 2026-03-18FDA Approved: VIGABATRIN — Supplemental Application (Par Health USA, LLC)
FDA approved a supplemental application for Vigabatrin from Par Health USA, LLC under the ANDA (ANDA208218). This action represents added re…
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FDA approval · 2026-03-18FDA Approved: VIGABATRIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for Vigabatrin submitted by Amneal Pharmaceuticals NY LLC.
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FDA approval · 2026-03-18FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)
FDA approved a supplemental application for SABRIL (vigabatrin) filed by Lundbeck Pharmaceuticals LLC.
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FDA approval · 2026-03-18FDA Approved: VIGABATRIN — Supplemental Application (Dr. Reddys Laboratories Inc.,)
FDA approved a supplemental application for Vigabatrin submitted by Dr. Reddys Laboratories Inc.
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FDA approval · 2026-03-18FDA Approved: VIGABATRIN — Supplemental Application (Carnegie Pharmaceuticals LLC)
The FDA approved a supplemental application for Vigabatrin submitted by Carnegie Pharmaceuticals LLC.
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FDA approval · 2026-03-18FDA Approved: VIGABATRIN — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)
FDA approved a supplemental application for Vigabatrin submitted by Zydus Pharmaceuticals (USA) Inc. The approval confirms the supplemental …
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FDA approval · 2026-03-18FDA Approved: VIGABATRIN — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for Vigabatrin from Ascend Laboratories, LLC (ANDA 213375).
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EMA approval · 2026-02-27EMA Authorised: Ztalmy (ganaxolone) — Marinus Pharmaceuticals Emerald Limited
The European Medicines Agency authorized Ztalmy (ganaxolone) for infantile epileptic spasms and related epileptic syndromes, marking EU appr…
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EMA approval · 2026-02-19EMA Authorised: Kigabeq (vigabatrin) — ORPHELIA Pharma
The EMA has authorised Kigabeq (vigabatrin) by ORPHELIA Pharma for infantile spasms and partial epilepsies.
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FDA approval · 2025-09-03FDA Approved: VIGAFYDE — Supplemental Application (Upsher-Smith Laboratories, LLC)
FDA approved a supplemental application for VIGAFYDE (vigabatrin) submitted by Upsher-Smith Laboratories, LLC. The action updates the produc…
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FDA approval · 2024-12-17FDA Approved: VIGABATRIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)
The FDA approves a supplemental application for Vigabatrin from Amneal Pharmaceuticals NY LLC.
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FDA approval · 2024-09-12FDA Approved: VIGABATRIN — Supplemental Application (Novadoz Pharmaceuticals LLC)
FDA approved a supplemental application for Vigabatrin by Novadoz Pharmaceuticals LLC. This action represents regulatory approval of an upda…
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FDA approval · 2024-09-12FDA Approved: VIGABATRIN — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for Vigabatrin by Ascend Laboratories, LLC. The approval updates the regulatory status for Vigabatri…