Renal Cell Carcinoma

• FDA approval · 2022-06-07
  FDA Approved: SORAFENIB — Original Application (Dr.Reddys Laboratories Inc)

  FDA approves the original application for a generic sorafenib product from Dr. Reddy's Laboratories Inc, expanding access to the cancer drug…

• FDA approval · 2022-04-13
  FDA Approved: ALYMSYS — Original Application (Amneal Pharmaceuticals LLC)

  FDA approves ALYMSYS as a biosimilar to bevacizumab (bevaczizumab-maly) from Amneal Pharmaceuticals LLC under an original Biologics License …

• FDA approval · 2022-04-11
  FDA Approved: SUNITINIB MALATE — Original Application (Dr.Reddys Laboratories Inc)

  FDA approved a generic version of sunitinib malate (SUNITINIB MALATE) from Dr. Reddy's Laboratories Inc under Original Application.

• FDA approval · 2021-12-13
  FDA Approved: VOTRIENT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for VOTRIENT (pazopanib hydrochloride) from Novartis Pharmaceuticals Corporation. Pazopanib is used …

• FDA approval · 2021-12-06
  FDA Approved: SUNITINIB MALATE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved a generic version of sunitinib malate submitted by Mylan Pharmaceuticals Inc., for use in cancer indications shared with the re…

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• FDA approval · 2021-10-18
  FDA Approved: EVEROLIMUS — Original Application (Par Health USA, LLC)

  FDA approved Par Health USA, LLC's Original Application for EVEROLIMUS (a generic version of everolimus). The approval enables the generic p…

• FDA approval · 2021-08-30
  FDA Approved: SUTENT — Supplemental Application (U.S. Pharmaceuticals)

  The FDA approved a supplemental application for Sutent (sunitinib malate) submitted by U.S. Pharmaceuticals, enabling an updated indication …

• FDA approval · 2021-08-16
  FDA Approved: SUNITINIB MALATE — Original Application (NorthStar RxLLC)

  FDA approved the original application for sunitinib malate, authorizing a generic version of the cancer drug from NorthStar RxLLC.

• FDA approval · 2021-03-10
  FDA Approved: FOTIVDA — Original Application (AVEO Pharmaceuticals, Inc.)

  FDA approved Fotivda (tivozanib) as the original US approval for adults with relapsed or refractory renal cell carcinoma following one prior…

• FDA approval · 2021-02-11
  FDA Approved: EVEROLIMUS — Original Application (NorthStar RxLLC)

  FDA approved NorthStar RxLLC's original application (ANDA) for Everolimus, a generic version of the mTOR inhibitor. The approval enables a g…

• FDA approval · 2020-11-12
  FDA Approved: SORAFENIB — Original Application (Teva Pharmaceuticals, Inc.)

  The FDA approved Teva's original application for a generic sorafenib product, enabling a generic version of the cancer drug Sorafenib to be …

• FDA approval · 2020-09-10
  FDA Approved: SORAFENIB TOSYLATE — Original Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a generic sorafenib tosylate product from Mylan under an original application. Sorafenib is indicated for hepatocellular ca…

• FDA approval · 2020-08-17
  FDA Approved: VOTRIENT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for VOTRIENT (pazopanib hydrochloride) by Novartis Pharmaceuticals Corporation. The approval updates…

• FDA approval · 2020-07-17
  FDA Approved: VOTRIENT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for VOTRIENT (pazopanib hydrochloride) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2020-06-08
  FDA Approved: EVEROLIMUS — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s generic Everolimus under an Original Application, enabling the sale of a generic version of th…

• FDA approval · 2020-06-02
  FDA Approved: VOTRIENT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for VOTRIENT (pazopanib hydrochloride) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2020-02-13
  FDA Approved: AFINITOR — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Afinitor (everolimus) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2020-01-23
  FDA Approved: INLYTA — Supplemental Application (U.S. Pharmaceuticals)

  The FDA approved a supplemental application for INLYTA (axitinib) submitted by U.S. Pharmaceuticals.

• FDA approval · 2019-08-16
  FDA Approved: TEMSIROLIMUS — Original Application (Fresenius Kabi USA, LLC)

  FDA approved Fresenius Kabi USA, LLC's temsirolimus injection as an original generic application (ANDA) for the treatment of advanced renal …

• FDA approval · 2019-06-27
  FDA Approved: ZIRABEV — Original Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approves ZIRABEV (bevacizumab-bvzr) from Pfizer as a biosimilar to Avastin under an Original Application. The approval covers multiple b…

• FDA approval · 2019-05-17
  FDA Approved: PROLEUKIN — Supplemental Application (Iovance Biotherapeutics, Inc)

  FDA approved a supplemental application for PROLEUKIN (aldesleukin) filed by Iovance Biotherapeutics. The approval updates the product label…

• FDA approval · 2018-08-10
  FDA Approved: INLYTA — Supplemental Application (U.S. Pharmaceuticals)

  The FDA approved a supplemental application for INLYTA (axitinib) submitted by U.S. Pharmaceuticals.

• FDA approval · 2018-07-30
  FDA Approved: TEMSIROLIMUS — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare's original ANDA for temsirolimus, a generic version of the cancer drug used to treat advanced renal cell carc…

• FDA approval · 2018-06-06
  FDA Approved: LENVIMA — Supplemental Application (Eisai Inc.)

  FDA approved a supplemental application for LENVIMA (lenvatinib) submitted by Eisai Inc.

• FDA approval · 2018-04-12
  FDA Approved: EVEROLIMUS — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s Original Application for Everolimus, establishing a generic version of the branded drug. The a…