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{ Tag Archives } Skin And Skin

Discontinuation Of Sale Of Ceftobiprole In Canada

Basilea Pharmaceutica Ltd. (SIX: BSLN) announces that Janssen-Ortho Inc., a Johnson & Johnson company, has in consultation with Health Canada decided to discontinue sale of ceftobiprole (ZEFTERA™) for the treatment of complicated skin and skin structure infections (cSSSI) in Canada. Janssen-Ortho Inc…

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FDA Issues Complete Response Letter For Ceftobiprole

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for ceftobiprole. The New Drug Application (NDA) was originally submitted to the FDA in May 2007 for the treatment of complicated skin and skin structure infections (cSSSI), including diabetic foot [...]

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Novexel Starts Phase II Clinical Trial With NXL103 In Adults With Acute Bacterial Skin And Skin Structure Infections (ABSSSI)

Novexel, a speciality pharmaceutical company focused on the discovery and development of novel antibiotics designed to overcome the significant global problem of microbial resistance, announces that its most advanced oral antibacterial NXL103 (flopristin/linopristin), has started a Phase II clinical trial in adults with acute bacterial skin and skin structure infections (ABSSSI).

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Theravance And Astellas Announce The Commercial Launch Of VIBATIVTM (telavancin) In The United States

Theravance, Inc. (NASDAQ: THRX) and Astellas Pharma US, Inc. announced today the commercial launch of VIBATIV™ (telavancin) in the United States. On September 11, 2009, the U.S. Food and Drug Administration (FDA) approved VIBATIV for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus [...]

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Theravance And Astellas Announce FDA Approval Of VIBATIVTM (telavancin) For The Treatment Of Complicated Skin And Skin Structure Infections

Theravance, Inc. (NASDAQ: THRX) and Astellas Pharma US, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved VIBATIV™ (telavancin) for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains.

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Basilea Pharmaceutica Ltd.: FDA Accepts For Review The Complete Response Submission To Ceftobiprole NDA

Basilea Pharmaceutica Ltd. (SWISS: BSLN) announces that the U.S. Food and Drug Administration (FDA) has accepted the response submitted by the sponsor Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (PRD) as complete. The Complete Response submission addresses the FDA Complete Response Letter issued in November 2008 concerning the ceftobiprole NDA for complicated skin and [...]

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The Medicines Company Withdraws European Marketing Application For 3-7 Day Daily Dose Oritavancin Therapy

The Medicines Company (NASDAQ: MDCO) announced the withdrawal of the European marketing authorization application (MAA) for the 200mg 3-7 day daily dose therapy of oritavancin, its investigational antibiotic drug candidate for the treatment of complicated skin and skin structure infections (cSSSI) caused by gram positive pathogens. The MAA was filed in Europe in [...]

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Skin And Skin Structure Infections Are The Second Most Common Diagnoses For Which An Antibiotic Is Used In The Hospital Setting

Arlington Medical Resources (AMR), a provider of premier market intelligence for the pharmaceutical and diagnostic imaging industries, finds that for the July – December 2008 time period, skin and skin structure infections continue to be the second most common diagnoses for which an antibiotic is used in the hospital setting. Antibiotic use for these infections [...]

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FDA Accepts For Review Theravance’s Complete Response Submission For Telavancin For The Treatment Of Complicated Skin And Skin Structure Infections

Theravance, Inc. (NASDAQ: THRX) announced that the U.S. Food and Drug Administration (FDA) accepted as complete for review Theravance’s response to the February 2009 Complete Response letter, which outlined requirements for approval of telavancin for the treatment of complicated skin and skin structure infections (cSSSI).

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