Pheochromocytoma

• FDA approval · 2025-04-09
  FDA Approved: METYROSINE — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved the original application for metyrosine (METYROSINE) from Dr. Reddy's Laboratories Inc., marking the approval of this generic p…

• FDA approval · 2023-05-08
  FDA Approved: PHENOXYBENZAMINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for phenoxybenzamine hydrochloride manufactured by Aurobindo Pharma Limited.

• FDA approval · 2022-07-19
  FDA Approved: PHENOXYBENZAMINE HYDROCHLORIDE — Original Application (Novitium Pharma LLC)

  FDA approved the original ANDA for phenoxybenzamine hydrochloride (generic) from Novitium Pharma LLC. The product is now available as a gene…

• FDA approval · 2020-10-27
  FDA Approved: PHENOXYBENZAMINE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved phenoxybenzamine hydrochloride under an original ANDA for Amneal Pharmaceuticals NY LLC.

• FDA approval · 2020-07-24
  FDA Approved: METYROSINE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal Pharmaceuticals NY LLC's generic metyrosine (METYROSINE) under Original Application ANDA213734.

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• FDA approval · 2019-03-22
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Breckenridge Pharmaceutical, Inc.)

  The FDA approved Breckenridge Pharmaceutical's supplemental application for propranolol hydrochloride (generic propranolol HCl).

• CLINICAL_TRIALS approval · 2019-01-30
  Clinical Trial Update: Expanded Access Program of Ultratrace Iobenguane I131 for Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma

  Marketing approval for Ultratrace iobenguane I-131 has been granted for malignant relapsed/refractory pheochromocytoma and paraganglioma, pe…

• FDA approval · 2014-07-15
  FDA Approved: DEMSER — Supplemental Application (Bausch Health US, LLC)

  The FDA approved a supplemental application for Demser (metyrosine) submitted by Bausch Health US, LLC. The approval updates the drug's labe…

• FDA approval · 2013-11-08
  FDA Approved: DEMSER — Supplemental Application (Bausch Health US, LLC)

  FDA approved a supplemental application for DEMSER (metyrosine) filed by Bausch Health US, LLC.

• FDA approval · 2013-03-20
  FDA Approved: ADREVIEW — Supplemental Application (Medi-Physics Inc.)

  FDA approved a supplemental application for ADREVIEW (Iobenguane I-123) from Medi-Physics Inc. to update its labeling/indications as a radio…

• FDA approval · 2012-01-27
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Ipca Laboratories Limited)

  FDA approved a supplemental application for propranolol hydrochloride from Ipca Laboratories Limited, finalizing a regulatory update for the…

• FDA approval · 2008-09-19
  FDA Approved: ADREVIEW — Original Application (Medi-Physics Inc.)

  FDA approved the original application for ADREVIEW (IOBENGUANE I-123) from Medi-Physics Inc., a radiopharmaceutical imaging agent for locati…

• FDA approval · 2008-09-10
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for propranolol hydrochloride from Hikma Pharmaceuticals USA Inc., indicating regulatory approval of…

• FDA approval · 2007-06-21
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for propranolol hydrochloride (generic) from Hikma Pharmaceuticals USA Inc., indicating an approval …

• FDA approval · 2007-01-03
  FDA Approved: INDERAL LA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for INDERAL LA (propranolol hydrochloride) submitted by ANI Pharmaceuticals, Inc. This action au…