Tuberculosis

• FDA approval · 2023-08-16
  FDA Approved: RIFAMPIN — Supplemental Application (EPIC PHARMA, LLC)

  FDA approved a supplemental application for Rifampin from Epic Pharma, LLC. The approval likely updates labeling or indications for the prod…

• FDA approval · 2023-06-30
  FDA Approved: RIFAMPIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved a Lupin Pharmaceuticals supplemental application for Rifampin (ANDA 090034), resulting in an approved update to the generic…

• FDA approval · 2022-12-21
  FDA Approved: PRETOMANID — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Pretomanid, submitted by Viatris Specialty LLC.

• FDA approval · 2022-01-29
  FDA Approved: RIFADIN IV — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for the IV formulation Rifadin (rifampin) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2022-01-19
  FDA Approved: RIFAMPIN — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for Rifampin from Chartwell RX, LLC under an ANDA. This confirms approval of a generic Rifampin prod…

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• FDA approval · 2021-09-23
  FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)

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

• FDA approval · 2021-09-14
  FDA Approved: RIFAMPIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for Rifampin under the ANDA. The approval indicates changes to the Rifampin pro…

• FDA approval · 2021-09-13
  FDA Approved: RIFAMPIN — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for Rifampin (RIFAMPIN) submitted by Chartwell RX, LLC under ANDA065390.

• FDA approval · 2021-09-13
  FDA Approved: RIFAMPIN — Supplemental Application (EPIC PHARMA, LLC)

  The FDA approved a supplemental application for Rifampin from Epic Pharma, LLC. The action pertains to changes under the Rifampin ANDA 06415…

• FDA approval · 2020-09-02
  FDA Approved: RIFAMPIN — Supplemental Application (Chartwell RX, LLC)

  FDA approves Chartwell RX, LLC's supplemental application for rifampin (RIFAMPIN).

• FDA approval · 2020-08-17
  FDA Approved: RIFAMPIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Rifampin from Lupin Pharmaceuticals, approving an addition or change to the existing Rifampin pr…

• FDA approval · 2020-07-27
  FDA Approved: PYRAZINAMIDE — Original Application (Macleods Pharmaceuticals Limited)

  The FDA approved a generic version of pyrazinamide under an original application filed by Macleods Pharmaceuticals Limited.

• FDA approval · 2020-07-01
  FDA Approved: RIFAMPIN — Supplemental Application (Mylan Institutional LLC)

  The FDA approved a supplemental application for Rifampin filed by Mylan Institutional LLC (ANDA065421). This action represents a supplementa…

• FDA approval · 2020-06-09
  FDA Approved: PRIFTIN — Supplemental Application (sanofi-aventis U.S. LLC)

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

• FDA approval · 2020-06-05
  FDA Approved: PRIFTIN — Supplemental Application (sanofi-aventis U.S. LLC)

  The FDA approved a supplemental application for PRIFTIN (rifapentine) from Sanofi-US LLC, signaling regulatory approval related to a labelin…

• FDA approval · 2020-05-27
  FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)

  The FDA approved a supplemental application for SIRTURO (bedaquiline fumarate) submitted by Janssen Products, LP, updating the drug's approv…

• FDA approval · 2020-01-06
  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 · 2019-08-27
  FDA Approved: RIFADIN IV — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application to authorize the intravenous rifampin formulation RIFADIN IV from Sanofi-Aventis U.S. LLC.

• FDA approval · 2019-08-15
  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 · 2019-08-09
  FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)

  FDA approves Janssen's supplemental application for SIRTURO (bedaquiline fumarate).

• FDA approval · 2019-01-23
  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, updating the labeling to include the intrave…

• FDA approval · 2018-11-08
  FDA Approved: CYCLOSERINE — Supplemental Application (Dr. Reddys Laboratories, Inc.)

  FDA approved a supplemental application for cycloserine from Dr. Reddy's Laboratories, Inc. (ANDA 060593).

• FDA approval · 2018-01-08
  FDA Approved: RIFADIN IV — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Rifadin IV (rifampin) submitted by Sanofi-Aventis U.S. LLC to support the intravenous formulatio…

• CLINICAL_TRIALS approval · 2017-11-27
  Clinical Trial Update: Early Access of TMC207 in Patients With Extensively Drug Resistant or Pre-XDR Pulmonary Tuberculosis

  The document notes marketing approval for TMC207 (bedaquiline) to treat extensively drug-resistant or pre-XDR pulmonary tuberculosis through…

• FDA approval · 2017-04-24
  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.