Homocystinuria

• EMA approval · 2026-03-10
  EMA Authorised: Amversio (betaine) — SERB SA

  The European Medicines Agency has authorized Amversio as a betaine product for homocystinuria, with SERB SA as the marketing authorization h…

• EMA approval · 2024-12-12
  EMA Authorised: Cystadane (Betaine anhydrous) — Recordati Rare Diseases

  EMA has authorised Cystadane (betaine anhydrous) for homocystinuria, with Recordati Rare Diseases as the marketing authorization holder.

• FDA approval · 2022-01-28
  FDA Approved: BETAINE ANHYDROUS — Original Application (Eton Pharmaceuticals, Inc.)

  The FDA approved an original generic application for betaine anhydrous, manufactured by Eton Pharmaceuticals. It is indicated for the treatm…

• FDA approval · 2021-11-23
  FDA Approved: BETAINE — Original Application (Cosette Pharmaceuticals, Inc.)

  FDA approved Cosette Pharmaceuticals' Betaine based on an Original Application (ANDA) for its use in treating homocystinuria.

• FDA approval · 2018-11-06
  FDA Approved: CYSTADANE — Supplemental Application (Recordati Rare Diseases)

  The FDA approved a supplemental application for CYSTADANE (betaine) submitted by Recordati Rare Diseases.

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• FDA approval · 2010-04-05
  FDA Approved: CYSTADANE — Supplemental Application (Recordati Rare Diseases)

  FDA approved a supplemental application for Cystadane (betaine) from Recordati Rare Diseases.