Ovarian Cancer

• FDA approval · 2022-12-16
  FDA Approved: CYTALUX — Supplemental Application (On Target Laboratories, Inc.)

  FDA approved a supplemental application for CYTALUX (pafolacianine injection) by On Target Laboratories, expanding the product's labeling. T…

• FDA approval · 2022-10-20
  FDA Approved: PACLITAXEL — Original Application (BluePoint Laboratories)

  FDA approves paclitaxel as a generic product under an original application from BluePoint Laboratories.

• FDA approval · 2022-07-27
  FDA Approved: PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND — Original Application (American Regent, Inc.)

  FDA approved paclitaxel protein-bound particles albumin-bound (paclitaxel) from American Regent, Inc. under an Original Application (NDA2118…

• 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 · 2021-11-29
  FDA Approved: CYTALUX — Original Application (On Target Laboratories, Inc.)

  The FDA approved Cytalux (pafolacianine injection) from On Target Laboratories for intraoperative visualization of folate receptor–positive …

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• FDA approval · 2021-09-09
  FDA Approved: TALZENNA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for TALZENNA (talazoparib) submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2020-08-20
  FDA Approved: TOPOTECAN HYDROCHLORIDE — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare's supplemental application for Topotecan Hydrochloride, a generic chemotherapy drug, supporting its labeling …

• FDA approval · 2020-05-15
  FDA Approved: RUBRACA — Supplemental Application (pharmaand GmbH)

  The FDA approved a supplemental application for RUBRACA (rucaparib) submitted by pharmaand GmbH.

• FDA approval · 2020-03-05
  FDA Approved: CARBOPLATIN — Supplemental Application (Apotex Corp.)

  The FDA approved a supplemental application for carboplatin filed by Apotex Corp., authorizing changes to an approved generic product.

• FDA approval · 2019-12-27
  FDA Approved: LYNPARZA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for LYNPARZA (olaparib) from AstraZeneca Pharmaceuticals LP. The approval updates the product labeli…

• FDA approval · 2019-10-03
  FDA Approved: GEMCITABINE HYDROCHLORIDE — Supplemental Application (Gland Pharma Limited)

  The FDA approved a supplemental application for gemcitabine hydrochloride from Gland Pharma Limited. This approval enables the marketing of …

• FDA approval · 2019-09-13
  FDA Approved: MELPHALAN HYDROCHLORIDE — Original Application (Qilu Pharmaceutical Co., Ltd.)

  FDA approved the original application for MELPHALAN HYDROCHLORIDE from Qilu Pharmaceutical Co., Ltd., granting approval of its generic produ…

• FDA approval · 2019-08-12
  FDA Approved: DOXORUBICIN HYDROCHLORIDE LIPOSOME — Supplemental Application (Baxter Healthcare Company)

  FDA approved a supplemental application for doxorubicin hydrochloride liposome submitted by Baxter Healthcare Company.

• FDA approval · 2019-05-28
  FDA Approved: MELPHALAN HYDROCHLORIDE — Original Application (Fosun Pharma USA Inc)

  FDA approved the original application for melphalan hydrochloride (generic) supplied by Fosun Pharma USA Inc for use in treating multiple my…

• FDA approval · 2019-04-01
  FDA Approved: DOCETAXEL — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  FDA approved a supplemental application for Docetaxel from Dr. Reddy's Laboratories Inc., authorizing the generic product under the approved…

• FDA approval · 2019-01-18
  FDA Approved: CYCLOPHOSPHAMIDE — Original Application (Cipla USA Inc.)

  The FDA approved Cipla USA Inc.'s original application for a generic cyclophosphamide product. This marks approval of a generic formulation …

• FDA approval · 2018-07-20
  FDA Approved: GEMCITABINE — Original Application (Sagent Pharmaceuticals)

  FDA approves Sagent Pharmaceuticals' original ANDA for gemcitabine, a generic injectable chemotherapy used to treat several cancers.

• FDA approval · 2018-04-30
  FDA Approved: DOCETAXEL — Original Application (Mylan Institutional LLC)

  The FDA approved Mylan Institutional LLC's original application for a generic docetaxel anhydrous product (ANDA208859).

• FDA approval · 2017-12-22
  FDA Approved: MELPHALAN — Original Application (Fresenius Kabi USA, LLC)

  The FDA approved Fresenius Kabi USA, LLC's original application for melphalan hydrochloride (melphalan hydrochloride) as a generic chemother…

• FDA approval · 2017-12-08
  FDA Approved: MELPHALAN HYDROCHLORIDE — Original Application (Dr.Reddy's Laboratories Inc)

  FDA approves Dr. Reddy's Laboratories' Melphalan hydrochloride as an original generic application.

• FDA approval · 2017-11-03
  FDA Approved: DOXORUBICIN HYDROCHLORIDE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for doxorubicin hydrochloride from BluePoint Laboratories, adding a new approved generic version of …

• CLINICAL_TRIALS approval · 2017-10-25
  Clinical Trial Update: Expanded Access Program for Olaparib Tablets as Maintenance Therapy in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer.

  Update notes that Olaparib is available via an expanded access program as maintenance therapy for ovarian, fallopian tube, or primary perito…

• FDA approval · 2017-08-03
  FDA Approved: GEMCITABINE — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare's gemcitabine injectable drug as an original application, providing a generic version of the anticancer agent…

• FDA approval · 2017-07-06
  FDA Approved: TOPOTECAN — Original Application (Accord Healthcare Inc.)

  The FDA approved Accord Healthcare Inc.'s original application for a generic Topotecan. This approval makes a generic version of Topotecan a…

• FDA approval · 2017-03-17
  FDA Approved: CISPLATIN — Original Application (Sagent Pharmaceuticals)

  FDA approved Sagent Pharmaceuticals' original application for cisplatin, a generic injectable chemotherapy agent (ANDA approval).