Skin and Soft Tissue Infections
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2021-03-30Clinical Trial Update: Safety, Efficacy, and Pharmacokinetics (PK) of Daptomycin (MK-3009) in Japanese Pediatric Subjects With Complicated Skin and Soft Tissue Infections (cSSTI) and Bacteremia (MK-3009-029) [Phase 2]
Phase 2 trial assessing safety, efficacy, and pharmacokinetics of daptomycin (MK-3009) in Japanese pediatric patients with complicated skin …
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FDA approval · 2021-03-16FDA Approved: PIPERACILLIN AND TAZOBACTAM — Supplemental Application (Eugia US LLC)
The FDA approved a supplemental application for Piperacillin and Tazobactam (piperacillin sodium and tazobactam sodium) submitted by Eugia U…
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FDA approval · 2021-02-19FDA Approved: CEFDINIR — Original Application (American Health Packaging)
FDA approves the original ANDA for cefdinir (CEFDINIR) by American Health Packaging, making a generic cefdinir product available.
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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 · 2020-07-27FDA Approved: NAFCILLIN — Supplemental Application (Athenex Pharmaceutical Division, LLC.)
FDA approved a supplemental application for Nafcillin (Nafcillin Sodium) by Athenex Pharmaceutical Division, LLC. The action constitutes a s…
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FDA approval · 2020-07-27FDA Approved: OXACILLIN — Original Application (Fresenius Kabi USA, LLC)
FDA approves Fresenius Kabi USA, LLC's Oxacillin sodium as an original-application (ANDA) generic antibiotic. It is indicated for infections…
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FDA label_change · 2020-05-26FDA Approved: ZOSYN IN GALAXY CONTAINERS — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
FDA approved a supplemental application for ZOSYN in Galaxy containers, a packaging/labeling change for the piperacillin/tazobactam product.…
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FDA approval · 2019-08-20FDA Approved: CLINDAMYCIN HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for clindamycin hydrochloride from Chartwell RX, LLC.
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FDA approval · 2019-08-16FDA Approved: MEROPENEM — Original Application (WG Critical Care, LLC)
FDA approved WG Critical Care, LLC's original ANDA for Meropenem, providing a generic version of the carbapenem antibiotic.
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FDA approval · 2019-08-14FDA Approved: METRONIDAZOLE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)
The FDA approved a supplemental application for Metronidazole from Unichem Pharmaceuticals (USA), Inc., supporting a generic version under A…
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FDA approval · 2019-06-12FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (Slate Run Pharmaceuticals, LLC)
FDA approved the vancomycin hydrochloride original application for Slate Run Pharmaceuticals, enabling a generic version of this antibiotic.
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FDA approval · 2019-05-28FDA Approved: LINEZOLID — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for LINEZOLID submitted by Sun Pharmaceutical Industries, Inc. The approval relates to changes to th…
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CLINICAL_TRIALS trial_result · 2018-11-30Clinical Trial Update: Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI [Phase 3]
Phase 3 trial comparing oral omadacycline to oral linezolid for acute bacterial skin and skin structure infections has completed with result…
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FDA approval · 2018-04-05FDA Approved: NAFCILLIN — Supplemental Application (Baxter Healthcare Corporation)
FDA approved a supplemental application for Nafcillin submitted by Baxter Healthcare Corporation under NDA 050655.
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CLINICAL_TRIALS trial_result · 2018-03-27Clinical Trial Update: Skin and Soft Tissue Infection (SSTI) Study [Phase 4]
A Phase 4 clinical trial studying skin and soft tissue infections has completed with results posted in 2018.
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FDA approval · 2018-02-21FDA Approved: VANCOMYCIN HYDROCHLORIDE — Supplemental Application (SAMSON MEDICAL TECHNOLOGIES LLC)
The FDA approved Samson Medical Technologies LLC's supplemental application for vancomycin hydrochloride, a generic antibiotic, under an app…
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FDA approval · 2017-07-14FDA Approved: NAFCILLIN — Supplemental Application (Baxter Healthcare Corporation)
The FDA approved a supplemental application for naficillin submitted by Baxter Healthcare Corporation.
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CLINICAL_TRIALS research · 2017-02-02Clinical Trial Update: Study of Accuracy of New Diagnostic Technology to Guide Rapid Antibiotic Treatment for Serious Infections
A completed clinical trial assessing the accuracy of a new diagnostic technology intended to guide rapid antibiotic treatment for serious in…
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CLINICAL_TRIALS trial_result · 2016-11-02Clinical Trial Update: A Study of Beta-Lactam in Hospitalized Patients With Skin and Skin Structure Infections [Phase 2]
A Phase 2 trial evaluating a beta-lactam antibiotic in hospitalized patients with skin and soft tissue infections has completed.
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FDA approval · 2016-08-04FDA Approved: LINEZOLID — Original Application (Eugia US LLC)
FDA approves a generic version of linezolid (ANDA 206917) for Eugia US LLC, expanding access to this antibiotic.
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CLINICAL_TRIALS trial_result · 2016-06-29Clinical Trial Update: S. Aureus, Skin and Soft Tissue Infections
The clinical trial NCT02796742 evaluating treatment for Staphylococcus aureus skin and soft tissue infections has completed. The trial was s…
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FDA approval · 2016-06-29FDA Approved: CEFTRIAXONE SODIUM — Original Application (Qilu Pharmaceutical Co., Ltd.)
FDA approved the Original Application for ceftriaxone sodium from Qilu Pharmaceutical Co., Ltd., a broad-spectrum cephalosporin used to trea…
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FDA approval · 2016-05-12FDA Approved: CLINDAMYCIN PHOSPHATE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)
FDA approved the supplemental application for clindamycin phosphate (Padagis Israel Pharmaceuticals Ltd), reflecting approval of the supplem…
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FDA approval · 2016-04-12FDA Approved: CEFUROXIME — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for Cefuroxime, adding an additional approved use/formulation under t…
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FDA approval · 2016-03-31FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (Eugia US LLC)
The FDA approved a generic vancomycin hydrochloride for injection under an original application from Eugia US LLC. This adds a generic IV op…