Complicated Skin and Skin Structure Infections
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Sign up freeTop drugs studied for this disease
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FDA approval · 2019-11-15FDA Approved: DAPTOMYCIN — Original Application (Sagent Pharmaceuticals)
FDA approved the original application for daptomycin by Sagent Pharmaceuticals, authorizing a generic injectable form of daptomycin.
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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 label_change · 2019-09-20FDA Approved: ERTAPENEM — Supplemental Application (ENDO USA, Inc.)
The FDA approved a supplemental application for ertapenem (ERTAPENEM SODIUM) submitted by ENDO USA, Inc.
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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 · 2019-08-22FDA Approved: DAPTOMYCIN — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma Pharmaceuticals USA Inc.'s generic daptomycin under an Original Application. The approval covers the same indications as …
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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.
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FDA approval · 2019-06-26FDA Approved: DAPTOMYCIN — Original Application (BE Pharmaceuticals Inc.)
FDA approved BE Pharmaceuticals Inc.'s original application for daptomycin, enabling the generic version of this antibiotic.
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FDA approval · 2019-06-24FDA Approved: DAPTOMYCIN — Original Application (Accord Healthcare Inc.)
FDA approves the original application for Daptomycin (generic) from Accord Healthcare Inc., authorizing its commercialization as a generic a…
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FDA approval · 2019-06-11FDA Approved: TIGECYCLINE — Original Application (Eugia US LLC)
FDA approved the original application for a generic tigecycline product by Eugia US LLC, enabling market availability of a generic tigecycli…
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FDA approval · 2018-12-21FDA Approved: TIGECYCLINE — Original Application (Apotex Corp)
FDA approves Apotex Corp's original application for tigecycline, granting approval of a generic version of the antibiotic.
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FDA approval · 2018-06-05FDA Approved: DAPTOMYCIN — Original Application (Mylan Institutional LLC)
FDA approved a generic daptomycin product from Mylan Institutional LLC via an Original Application. This approval provides a non-brand versi…
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FDA approval · 2018-04-11FDA Approved: DAPTOMYCIN — Original Application (Fresenius Kabi USA, LLC)
FDA listing shows Fresenius Kabi USA, LLC's original application approval for daptomycin, establishing its approval for complicated skin and…
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FDA approval · 2017-09-12FDA Approved: DAPTOMYCIN — Original Application (Sagent Pharmaceuticals)
FDA approval record for Daptomycin under an Original Application by Sagent Pharmaceuticals (NDA 208385). The entry documents FDA approval of…
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FDA label_change · 2016-12-21FDA Approved: DAPTOMYCIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved the supplemental application for daptomycin by Hikma Pharmaceuticals USA Inc., resulting in changes to the labeling and potenti…
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FDA approval · 2016-07-26FDA Approved: MOXIFLOXACIN — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for moxifloxacin hydrochloride (MOXIFLOXACIN) from Fresenius Kabi USA, LLC, indicating a modificatio…
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CLINICAL_TRIALS trial_result · 2016-07-25Clinical Trial Update: Daptomycin in the Treatment of Patients With Renal Insufficiency and Complicated Skin and Skin Structure Infections [Phase 4]
Phase 4 trial update for daptomycin in patients with renal insufficiency and soft tissue infections, including complicated skin and skin str…
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FDA approval · 2016-06-15FDA Approved: DAPTOMYCIN — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approved the original application for daptomycin, a bacterial antibiotic, as a generic version manufactured by Hikma Pharmaceuticals USA…
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CLINICAL_TRIALS trial_result · 2016-05-30Clinical Trial Update: Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment
Clinical trial evaluating the safety and effectiveness of tigecycline in subjects with complicated skin and skin structure infections and co…
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CLINICAL_TRIALS trial_result · 2015-05-13Clinical Trial Update: Study of Daptomycin Safety and Efficacy for Complicated Skin and Skin Structure Infections (cSSSI) and Bacteremia in Renal Impairment [Phase 4]
Phase 4 trial evaluating daptomycin safety and efficacy for complicated skin and skin structure infections and bacteremia in patients with r…
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CLINICAL_TRIALS trial_result · 2015-01-13Clinical Trial Update: Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections [Phase 2, Phase 3]
Phase 2/3 clinical trial evaluating ceftaroline fosamil versus a comparator in pediatric patients with complicated skin and skin structure i…
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CLINICAL_TRIALS trial_result · 2014-12-08Clinical Trial Update: A Study to Assess Efficacy and Safety of IV/PO Moxifloxacin in the Treatment of cSSSIs [Phase 3]
A Phase 3 trial evaluating IV/PO moxifloxacin for complicated skin and skin structure infections has completed.
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FDA approval · 2014-03-13FDA Approved: VIBATIV — Supplemental Application (Cumberland Pharmaceuticals Inc.)
FDA approved a supplemental labeling application for VIBATIV (telavancin hydrochloride) submitted by Cumberland Pharmaceuticals. The approva…
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FDA approval · 2013-12-12FDA Approved: VIBATIV — Supplemental Application (Cumberland Pharmaceuticals Inc.)
FDA approved a supplemental application for Vibativ (telavancin hydrochloride) from Cumberland Pharmaceuticals Inc.
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FDA approval · 2013-02-01FDA Approved: VIBATIV — Supplemental Application (Cumberland Pharmaceuticals Inc.)
FDA approved a supplemental application for VIBATIV (telavancin hydrochloride) from Cumberland Pharmaceuticals, updating the labeling under …
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CLINICAL_TRIALS trial_result · 2011-12-16Clinical Trial Update: Efficacy and Safety Study of JNJ-32729463 for Treating Complicated Skin and Skin Structure Infections Compared to Linezolid (Zyvox) [Phase 2]
The document reports the completion of a Phase 2 efficacy and safety trial comparing JNJ-32729463 to Linezolid for complicated skin and skin…