Tuberculosis

• FDA approval · 2016-02-10
  FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)

  The FDA approved a supplemental application for SIRTURO (bedaquiline fumarate) from Janssen Products, LP.

• FDA approval · 2015-12-09
  FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)

  The FDA approved a supplemental application for SIRTURO (bedaquiline fumarate) from Janssen Products, LP.

• FDA approval · 2015-12-02
  FDA Approved: RIFADIN IV — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Rifadin IV (rifampin) from Sanofi-Aventis U.S. LLC, signaling a new or expanded regulatory appro…

• FDA approval · 2015-07-01
  FDA Approved: RIFABUTIN — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Rifabutin from Mylan Pharmaceuticals Inc., updating labeling and approved uses.

• FDA approval · 2015-07-01
  FDA Approved: PRIFTIN — Supplemental Application (sanofi-aventis U.S. LLC)

  FDA approved a supplemental application for Priftin (rifapentine) by Sanofi-Aventis U.S. LLC, updating the drug’s labeling.

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• FDA approval · 2015-05-14
  FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)

  FDA approved a supplemental application for SIRTURO (bedaquiline fumarate) filed by Janssen Products, LP.

• FDA approval · 2015-04-09
  FDA Approved: RIFADIN IV — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for RIFADIN IV (rifampin) submitted by Sanofi-Aventis U.S. LLC, approving the intravenous formul…

• FDA approval · 2014-11-25
  FDA Approved: PRIFTIN — Supplemental Application (sanofi-aventis U.S. LLC)

  The FDA approved a supplemental application for PRIFTIN (rifapentine) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2014-08-21
  FDA Approved: RIFAMPIN — Original Application (Fresenius Kabi USA, LLC)

  FDA approved Fresenius Kabi USA, LLC's generic rifampin (RIFAMPIN) under an Original Application (ANDA), expanding access to this antibiotic…

• FDA approval · 2014-08-04
  FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)

  FDA approved a supplemental application for SIRTURO (bedaquiline fumarate) from Janssen Products, LP, likely updating the labeling or expand…

• FDA approval · 2014-03-19
  FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)

  FDA approved a supplemental application for SIRTURO (bedaquiline fumarate) from Janssen Products, LP, resulting in changes to the drug’s lab…

• FDA approval · 2013-08-28
  FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)

  The FDA approved a supplemental application for SIRTURO (bedaquiline fumarate) submitted by Janssen Products, LP.

• FDA approval · 2013-08-21
  FDA Approved: RIFAMPIN — Original Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' original application for rifampin, making a generic rifampin product available through an approved A…

• FDA approval · 2013-02-27
  FDA Approved: RIFADIN IV — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application to add an intravenous formulation of Rifadin (rifampin) from Sanofi-Aventis U.S. LLC.

• FDA approval · 2013-02-22
  FDA Approved: ETHAMBUTOL HYDROCHLORIDE — Supplemental Application (Marlex Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Ethambutol Hydrochloride from Marlex Pharmaceuticals, Inc.

• FDA approval · 2012-12-28
  FDA Approved: SIRTURO — Original Application (Janssen Products, LP)

  FDA approved SIRTURO (bedaquiline fumarate) from Janssen as the original application for the treatment of multidrug-resistant tuberculosis.

• FDA approval · 2012-01-27
  FDA Approved: ETHAMBUTOL HYDROCHLORIDE — Supplemental Application (Epic Pharma, LLC)

  The FDA approved a supplemental application for Ethambutol hydrochloride by Epic Pharma, LLC.

• FDA approval · 2010-11-10
  FDA Approved: RIFADIN IV — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Rifadin IV (rifampin) by Sanofi-Aventis U.S. LLC to support its intravenous formulation.

• FDA approval · 2009-12-04
  FDA Approved: ISONIAZID — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application from Sandoz Inc. for isoniazid.

• FDA approval · 2009-06-17
  FDA Approved: ETHAMBUTOL HYDROCHLORIDE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' Ethambutol Hydrochloride as an original ANDA, enabling the generic product to enter the market.

• FDA approval · 2009-06-01
  FDA Approved: PRIFTIN — Supplemental Application (sanofi-aventis U.S. LLC)

  The FDA approved a supplemental application for PRIFTIN (rifapentine) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2008-10-30
  FDA Approved: ETHAMBUTOL HYDROCHLORIDE — Supplemental Application (Marlex Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Ethambutol Hydrochloride submitted by Marlex Pharmaceuticals under NDA 016320.

• FDA approval · 2008-05-22
  FDA Approved: RIFAMPIN — Original Application (Mylan Institutional LLC)

  FDA approved an Original Application for rifampin from Mylan Institutional LLC, enabling a generic rifampin product. This action approves th…

• FDA approval · 2008-03-28
  FDA Approved: RIFAMPIN — Original Application (Chartwell RX, LLC)

  FDA approved an Original Application (ANDA) for rifampin submitted by Chartwell RX, LLC. This marks approval of a generic rifampin product.

• FDA approval · 2006-08-22
  FDA Approved: ETHAMBUTOL HYDROCHLORIDE — Supplemental Application (Epic Pharma, LLC)

  FDA approved a supplemental application for Ethambutol hydrochloride from Epic Pharma, LLC.