Bacteremia
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-03-23EMA Authorised: Vaborem (meropenem trihydrate;vaborbactam) — Menarini International Operations Luxembourg S.A.
The European Medicines Agency authorised Vaborem, a meropenem trihydrate and vaborbactam combination, for use in several infections. It cove…
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EMA approval · 2025-11-07EMA Authorised: Cubicin (daptomycin)
The European Medicines Agency authorised Cubicin (daptomycin) for Gram-positive bacterial infections including bacteremia, soft tissue infec…
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FDA approval · 2025-04-30FDA Approved: DAPTOMYCIN IN SODIUM CHLORIDE — Supplemental Application (Baxter Healthcare Corporation)
FDA approves Baxter's supplemental application for daptomycin in sodium chloride, adding a saline formulation of the antibiotic.
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FDA approval · 2025-04-30FDA Approved: DAPTOMYCIN — Supplemental Application (Civica, Inc.)
FDA approved a supplemental application for daptomycin submitted by Civica, Inc.
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FDA approval · 2024-11-21FDA Approved: DAPTOMYCIN — Original Application (Par Health USA, LLC)
FDA approves the original application for daptomycin by Par Health USA, LLC, authorizing its use as an antibiotic for certain serious infect…
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FDA approval · 2024-08-29FDA Approved: DAPTOMYCIN — Original Application (Biocon Pharma Inc.)
FDA approved Biocon Pharma Inc.'s original application for daptomycin (DAPTOMYCIN), a generic antibiotic.
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FDA approval · 2024-04-05FDA Approved: DAPTOMYCIN — Supplemental Application (BE Pharmaceuticals Inc.)
The FDA approves BE Pharmaceuticals Inc.'s supplemental application for daptomycin. This action updates the regulatory status for the drug u…
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FDA approval · 2023-08-07FDA Approved: DAPTOMYCIN — Original Application (Mylan Institutional LLC)
FDA approves a generic version of daptomycin under an Original Application (ANDA) from Mylan Institutional LLC.
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FDA approval · 2023-02-27FDA Approved: DAPTOMYCIN IN SODIUM CHLORIDE — Supplemental Application (Baxter Healthcare Corporation)
FDA approved a supplemental application for Daptomycin in Sodium Chloride from Baxter, authorizing a saline formulation of the antibiotic.
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FDA approval · 2022-12-23FDA Approved: DAPTOMYCIN — Original Application (NorthStar RxLLC)
FDA approves NorthStar RxLLC's generic daptomycin (DAPTOMYCIN) under an Original ANDA. The approval confirms the generic's indication for us…
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FDA approval · 2022-11-13FDA Approved: DAPTOMYCIN — Supplemental Application (BE Pharmaceuticals Inc.)
FDA approved a supplemental application for DAPTOMYCIN filed by BE Pharmaceuticals Inc. The approval relates to an ANDA and updates the regu…
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FDA approval · 2022-09-23FDA Approved: DAPTOMYCIN — Original Application (NorthStar RxLLC)
The FDA approved the original application for daptomycin (generic) submitted by NorthStar RxLLC.
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FDA approval · 2022-01-25FDA Approved: DAPTOMYCIN IN SODIUM CHLORIDE — Original Application (Baxter Healthcare Corporation)
FDA approved Daptomycin in Sodium Chloride from Baxter Healthcare Corporation through an Original Application. The approval establishes a sa…
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FDA approval · 2021-11-18FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (Slate Run Pharmaceuticals, LLC)
FDA approved vancomycin hydrochloride as a generic drug under an Original Application from Slate Run Pharmaceuticals, LLC.
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FDA approval · 2021-11-12FDA Approved: VANCOMYCIN HYDROCHLORIDE — Supplemental Application (Plano Pharmaceuticals Inc.)
The FDA approved a supplemental application for Vancomycin hydrochloride by Plano Pharmaceuticals Inc., approving changes to the approved dr…
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FDA approval · 2021-10-26FDA Approved: ZYVOX — Supplemental Application (Pharmacia & Upjohn Company LLC)
The FDA approved a supplemental application for Zyvox (linezolid) from Pharmacia & Upjohn Company LLC.
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FDA approval · 2021-09-02FDA Approved: DAPTOMYCIN — Original Application (Eugia US LLC)
FDA approved the original application for daptomycin for Eugia US LLC, authorizing clearance of a generic daptomycin product.
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FDA approval · 2021-06-29FDA Approved: DAPTOMYCIN — Original Application (Meitheal Pharmaceuticals Inc.)
The FDA approved Meitheal Pharmaceuticals' generic daptomycin (daptomycin) under an original ANDA (ANDA 213623), authorizing its marketing a…
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FDA approval · 2021-05-05FDA Approved: DAPTOMYCIN — Supplemental Application (Civica, Inc.)
The FDA approved a supplemental application for Civica, Inc.'s daptomycin. This action approves an update requested in the supplemental subm…
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FDA approval · 2021-04-21FDA Approved: DAPTOMYCIN — Original Application (Hisun Pharmaceuticals USA, Inc.)
FDA approved the original application for daptomycin (generic) by Hisun Pharmaceuticals USA, Inc. for the approved indications of complicate…
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FDA approval · 2020-09-09FDA Approved: DAPTOMYCIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for daptomycin (Hikma Pharmaceuticals USA Inc.), covering an additional formulation/strength under a…
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FDA approval · 2020-08-31FDA Approved: DAPTOMYCIN — Original Application (Dr. Reddy's Laboratories Inc.,)
FDA approved the original application for daptomycin by Dr. Reddy's Laboratories Inc., marking the first generic approval for the drug. The …
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FDA approval · 2019-10-03FDA Approved: DAPTOMYCIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for daptomycin from Hikma Pharmaceuticals USA Inc. under ANDA206005. This represents a supplemen…
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FDA approval · 2019-09-18FDA Approved: DAPTOMYCIN — Supplemental Application (Civica, Inc.)
FDA approved a supplemental application for Daptomycin from Civica, Inc., approving an update to its labeling or indication.
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FDA approval · 2019-07-12FDA Approved: DAPTOMYCIN — Original Application (Accord Healthcare, Inc.)
FDA approved Accord Healthcare, Inc.'s original application for daptomycin (generic), authorizing a generic version of the antibiotic.