Benign Prostatic Hyperplasia

• FDA approval · 2010-06-15
  FDA Approved: DOXAZOSIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for doxazosin mesylate filed by Teva Pharmaceuticals USA, Inc. under ANDA075536.

• FDA approval · 2010-06-15
  FDA Approved: AVODART — Supplemental Application (Waylis Therapeutics LLC)

  The FDA approved a supplemental application for AVODART (dutasteride) submitted by Waylis Therapeutics LLC.

• FDA approval · 2010-06-14
  FDA Approved: JALYN — Original Application (Waylis Therapeutics)

  FDA approved JALYN, a fixed-dose combination of dutasteride and tamsulosin hydrochloride, from Waylis Therapeutics via an Original Applicati…

• FDA approval · 2010-06-10
  FDA Approved: FINASTERIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Finasteride from Aurobindo Pharma Limited under their ANDA. This approves the generic Finasterid…

• FDA approval · 2010-06-07
  FDA Approved: FINASTERIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original ANDA for finasteride, making a generic version of the drug available.

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• FDA approval · 2010-05-27
  FDA Approved: FINASTERIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approves a supplemental application for finasteride submitted by Dr. Reddy's Laboratories Limited, updating the regulatory status of thi…

• FDA approval · 2010-05-26
  FDA Approved: FINASTERIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Teva's generic finasteride, enabling continued marketing of the product.

• FDA approval · 2010-04-27
  FDA Approved: TAMSULOSIN HYDROCHLORIDE — Original Application (Sandoz Inc)

  FDA approved the original application for tamsulosin hydrochloride (generic) from Sandoz Inc, expanding availability of this medication.

• FDA approval · 2010-04-27
  FDA Approved: TAMSULOSIN HYDROCHLORIDE — Original Application (EXELAN PHARMACEUTICALS, INC.)

  FDA approved an original ANDA for tamsulosin hydrochloride, confirming a generic version of the drug.

• FDA approval · 2010-04-27
  FDA Approved: TAMSULOSIN HYDROCHLORIDE — Original Application (Zydus Lifesciences Limited)

  FDA approved the original ANDA for Tamsulosin Hydrochloride from Zydus Lifesciences Limited. Tamsulosin hydrochloride is a generic alpha-1 b…

• FDA approval · 2010-04-09
  FDA Approved: UROXATRAL — Supplemental Application (Advanz Pharma (US) Corp.)

  The FDA approved a supplemental application for UROXATRAL (alfuzosin hydrochloride) from Advanz Pharma (US) Corp.

• FDA approval · 2010-03-23
  FDA Approved: PROSCAR — Supplemental Application (Organon LLC)

  The FDA has approved a supplemental application for PROSCAR (finasteride) submitted by Organon LLC.

• FDA approval · 2010-03-16
  FDA Approved: CARDURA XL — Supplemental Application (Viatris Specialty LLC)

  FDA approves a supplemental application for Cardura XL (doxazosin mesylate) by Viatris Specialty LLC to modify or expand the labeling.

• FDA approval · 2010-03-02
  FDA Approved: TAMSULOSIN HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approves the Original Application for Tamsulosin Hydrochloride from Amneal Pharmaceuticals of New York LLC, a generic drug for benign pr…

• FDA approval · 2010-02-23
  FDA Approved: FINASTERIDE — Original Application (Accord Healthcare, Inc.)

  FDA approves Accord Healthcare's generic finasteride through an Original Application for the treatment of benign prostatic hyperplasia and a…

• FDA approval · 2010-02-01
  FDA Approved: CIALIS — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for Cialis (tadalafil) submitted by Eli Lilly and Company.

• FDA approval · 2010-01-14
  FDA Approved: DOXAZOSIN — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for doxazosin submitted by Mylan Pharmaceuticals.

• FDA approval · 2008-09-18
  FDA Approved: UROXATRAL — Supplemental Application (Advanz Pharma (US) Corp.)

  The FDA approved a supplemental application for UROXATRAL (alfuzosin hydrochloride) from Advanz Pharma (US) Corp., updating the existing NDA…

• FDA approval · 2008-08-07
  FDA Approved: FINASTERIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for finasteride by Teva Pharmaceuticals USA, Inc., finalizing an update to an existing generic f…

• FDA approval · 2008-08-07
  FDA Approved: CIALIS — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for Cialis (tadalafil) submitted by Eli Lilly and Company.

• FDA approval · 2008-05-06
  FDA Approved: UROXATRAL — Supplemental Application (Advanz Pharma (US) Corp.)

  FDA approved a supplemental application for UROXATRAL (alfuzosin HCl) from Advanz Pharma (US) Corp.

• FDA approval · 2008-03-31
  FDA Approved: AVODART — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for Avodart (dutasteride) filed by Waylis Therapeutics LLC.

• FDA approval · 2007-10-30
  FDA Approved: FINASTERIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for a generic finasteride manufactured by Aurobindo Pharma Limited.

• FDA approval · 2007-10-01
  FDA Approved: FINASTERIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves a supplemental application for finasteride by Teva Pharmaceuticals USA, Inc., confirming the generic product's approval under a…

• FDA approval · 2007-08-09
  FDA Approved: TERAZOSIN HYDROCHLORIDE — Supplemental Application (Apnar Pharma LP)

  The FDA approved a supplemental application for terazosin hydrochloride from Apnar Pharma LP, confirming the generic product's approval and …