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{ Tag Archives } Food And Drug Administration Fda

Sizing Up Nanotechnology: How Nanosized Particles May Affect Skin Care Products

The rapidly growing field of nanotechnology and its future use in cosmetic products holds both enormous potential and potential concern for consumers. Currently, major cosmetic manufacturers have imposed a voluntary ban on the use of nanoparticles in products while they await a ruling from the Food and Drug Administration (FDA) regarding the safety of this [...]

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First Fractional Laser FDA Cleared For Striae

Palomar Medical Technologies, Inc. is pleased to announce that the Lux1540™ Fractional non-ablative laser handpiece has received the first clearance by the United States Food and Drug Administration (FDA) for the treatment of striae (stretch marks) using a fractional laser…

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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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FDA Approves New Drug For Pain That Persists After Shingles

The US Food and Drug Administration (FDA) announced yesterday that it has approved Qutenza (capsaicin) 8% patch for the treatment of post-herpetic neuralgia (PHN), an often excruciating pain that can persist for weeks, months and even years in 10 to 15 per cent of people who get shingles. [...]

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FDA Approves New Drug Treatment For Long-Term Pain Relief After Shingles Attacks

The Food and Drug Administration (FDA) has approved the approval of Qutenza (capsaicin) 8% patch, a medicated skin patch that relieves the pain of post-herpetic neuralgia (PHN), a serious complication that can occur after a bout with shingles. Shingles is an outbreak of rash or blisters on the skin that is caused [...]

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Sol-Gel’s IND Application For Rosacea Accepted By FDA

Sol-Gel Technologies announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of Sol-Gel’s Investigational New Drug Application (IND) for DER45-EV Gel for the topical treatment of rosacea. This IND allows Sol-Gel to initiate Phase II studies with DER45-EV Gel in rosacea patients. DER45-EV Gel is an innovative topical product based [...]

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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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Merz Pharmaceuticals’ Belotero(R) Balance PMA Filing Formally Accepted For Review By The FDA

Merz Pharmaceuticals, LLC, a leading specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for review Merz’s premarket approval (PMA) application for Belotero(R) Balance. Belotero(R) Balance is a hyaluronic acid based monophasic gel dermal filler that utilizes a cohesive polydensified matrix (CPM(TM)) technology.

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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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