Pulmonary Arterial Hypertension

• FDA approval · 2020-12-22
  FDA Approved: AMBRISENTAN — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental ANDA from Zydus Lifesciences Limited for ambrisentan, authorizing a generic version for pulmonary arterial hyper…

• FDA approval · 2020-11-30
  FDA Approved: ADEMPAS — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for ADEMPAS (riociguat) filed by Bayer HealthCare Pharmaceuticals Inc.

• FDA approval · 2020-11-03
  FDA Approved: ORENITRAM — Supplemental Application (United Therapeutics Corporation)

  FDA approved a supplemental application for ORENITRAM (treprostinil) submitted by United Therapeutics Corporation.

• FDA approval · 2020-10-27
  FDA Approved: N/A — Original Application (Bostal LLC)

  FDA approved an original application for tadalafil (generic) by Bostal LLC under ANDA 208824.

• FDA approval · 2020-09-15
  FDA Approved: ADCIRCA — Supplemental Application (United Therapeutics Corporation)

  FDA approves a supplemental application for ADCIRCA (tadalafil) from United Therapeutics Corporation. The approval indicates the submitted s…

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• FDA approval · 2020-08-19
  FDA Tentative Approval: REMODULIN — Supplemental Application (United Therapeutics Corporation)

  FDA has issued tentative approval for a United Therapeutics supplemental submission for REMODULIN (treprostinil).

• FDA approval · 2020-07-15
  FDA Approved: SILDENAFIL — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal Pharmaceuticals NY LLC's supplemental application for sildenafil (generic sildenafil), authorizing the continued com…

• FDA approval · 2020-05-22
  FDA Approved: STERILE DILUENT FOR TREPROSTINIL — Original Application (Dr.Reddy's Laboratories Inc.,)

  FDA approved the Original Application for a sterile diluent (water) intended for use with treprostinil, manufactured by Dr. Reddy's Laborato…

• FDA approval · 2020-04-20
  FDA Approved: AMBRISENTAN — Supplemental Application (Cipla USA Inc.)

  The FDA approved Cipla USA Inc.'s supplemental application for Ambrisentan.

• FDA approval · 2020-04-20
  FDA Approved: AMBRISENTAN — Supplemental Application (Zydus Lifesciences Limited)

  FDA approves a supplemental application for AMBRISENTAN by Zydus Lifesciences Limited, resulting in approval of a generic ambrisentan produc…

• FDA approval · 2020-04-08
  FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

  The FDA approved a supplemental application for OPSUMIT (macitentan) by Actelion Pharmaceuticals US, Inc., updating the product labeling via…

• FDA approval · 2020-03-02
  FDA Approved: SILDENAFIL — Original Application (Exelan Pharmaceuticals, Inc.)

  FDA approves an Original Application (ANDA) for sildenafil by Exelan Pharmaceuticals, enabling a generic version of the erectile dysfunction…

• FDA approval · 2020-02-21
  FDA Approved: REVATIO — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for REVATIO (sildenafil citrate) filed by Viatris Specialty LLC. The action typically updates or exp…

• FDA approval · 2020-02-21
  FDA Approved: SILDENAFIL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for sildenafil from Aurobindo Pharma Limited.

• FDA approval · 2020-02-21
  FDA Approved: TADALAFIL — Supplemental Application (Dr.Reddys Laboratories Inc)

  FDA approved a supplemental application for tadalafil submitted by Dr.Reddys Laboratories Inc.

• FDA approval · 2020-02-14
  FDA Approved: AMBRISENTAN — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for ambrisentan from Cipla USA Inc., indicating approval of a supplemental filing for the generic dr…

• FDA approval · 2020-02-14
  FDA Approved: AMBRISENTAN — Supplemental Application (Zydus Lifesciences Limited)

  This entry documents a supplemental application for ambrisentan submitted by Zydus Lifesciences Limited to the FDA.

• FDA approval · 2020-02-10
  FDA Approved: ADEMPAS — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  The FDA approved a supplemental application for ADEMPAS (riociguat) submitted by Bayer HealthCare Pharmaceuticals Inc.

• FDA approval · 2020-01-15
  FDA Approved: SILDENAFIL — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for sildenafil from Amneal Pharmaceuticals of New York LLC to market a generic sildenafil produc…

• FDA approval · 2019-12-09
  FDA Approved: AMBRISENTAN — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for ambrisentan filed by Zydus Lifesciences Limited under the ANDA framework.

• FDA approval · 2019-11-27
  FDA Approved: SILDENAFIL — Original Application (Ajanta Pharma USA Inc.)

  FDA approves Ajanta Pharma USA Inc.'s original application for sildenafil (generic) for use in erectile dysfunction and pulmonary arterial h…

• FDA approval · 2019-11-06
  FDA Approved: AMBRISENTAN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' supplemental application for AMBRISENTAN (ambrisentan), authorizing the generic version's approv…

• FDA approval · 2019-11-06
  FDA Approved: AMBRISENTAN — Supplemental Application (Cipla USA Inc.)

  The FDA approved a supplemental application for ambrisentan from Cipla USA Inc., authorizing a supplemental approval under ANDA210715.

• FDA approval · 2019-11-06
  FDA Approved: AMBRISENTAN — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for a generic ambrisentan from Mylan Pharmaceuticals.

• FDA approval · 2019-11-01
  FDA Approved: BOSENTAN — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Bosentan from Zydus Pharmaceuticals USA Inc., authorizing a generic bosentan product for pulmona…