FDA Policy/General

Product Approval Summaries

DEVICES

AliveCor has received FDA 510(k) clearance for its Heart Monitor, a mobile ECG device, compatible with the iPhone 4 and 4S models, that enables doctors to evaluate patient heart health remotely.

Ethicon Biosurgery has received FDA approval for the Evarrest Fibrin Sealant Patch, intended for use as an aid in stopping problematic bleeding during surgery. The patch is indicated for use with manual compression as an adjunct to hemostasis for soft tissue bleeding during open retroperitoneal, intra-abdominal, pelvic and non-cardiac thoracic surgery, when control of bleeding by standard hemostasis methods (e.g., suture, ligature, cautery) is ineffective or impractical. The company says it is not for use in children under one month of age and it cannot safely or effectively be used in place of sutures or other forms of mechanical ligation in treating major arterial or venous bleeding.

Devicor Medical Products has received FDA approval of the Mammotome Revolve, a dual vacuum-assisted biopsy system used to provide tissue specimens. The device features an “advanced specimen management system capable of collecting and organizing high quality individual tissue samples in numbered, specimen radiograph and pathology-ready chambers that preserve tissue integrity,” according to the company. It also features patented DualVac vacuum technology that gives clinicians the ability to secure contiguous tissue samples.

HUMAN DRUGS

Mylan Pharmaceuticals has received FDA approval of an ANDA for candesartan cilexetil and hydrochlorothiazide tablets (16/12.5 mg, 32/12.5 mg and 32/25 mg), a generic copy of AstraZeneca’s hypertension drug Atacand HCT. The fixed-dose combination is not indicated for initial therapy, according to the company.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome