Hairy Cell Leukemia

• FDA approval · 2026-03-27
  FDA Approved: CLADRIBINE — Original Application (Sandoz Inc.)

  FDA approved Sandoz's generic version of cladribine under an original ANDA.

• FDA approval · 2025-11-24
  FDA Approved: CLADRIBINE — Original Application (Apotex Corp.)

  FDA approves Apotex Corp.'s original ANDA for cladribine, a generic version of the cancer drug, intended for hairy cell leukemia.

• FDA approval · 2025-11-03
  FDA Approved: NIPENT — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Nipent (pentostatin) submitted by Hospira, Inc.

• EMA approval · 2025-04-03
  EMA Authorised: Litak (cladribine) — Lipomed GmbH

  The European Medicines Agency authorized Litak, a cladribine product from Lipomed GmbH, for hairy cell leukemia.

• FDA approval · 2019-10-28
  FDA Approved: NIPENT — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Nipent (pentostatin) submitted by Hospira, Inc., approving the requested supplemental change to …

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2015-12-29
  FDA Approved: NIPENT — Supplemental Application (Hospira, Inc.)

  The FDA approved a supplemental application for Nipent (pentostatin) from Hospira.

• FDA approval · 2013-06-20
  FDA Approved: NIPENT — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Nipent (pentostatin) submitted by Hospira, Inc.

• FDA approval · 2013-01-08
  FDA Approved: CLADRIBINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Cladribine from Hikma Pharmaceuticals USA Inc.

• FDA approval · 2009-09-22
  FDA Approved: NIPENT — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Nipent (pentostatin) submitted by Hospira, Inc.