Drugs

Doxycycline Expiration Extension Guidance

FDA has published a guidance, Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles, to help government public health and emergency response stakeholders determine if stockpiled doxycycline tablets and capsules have retained their purity and potency beyond the manufacturer’s labeled expiration date so the replacement of stockpiled product could be deferred. The document refers to doxycycline tablets and capsules stockpiled by government stakeholders for public health emergency preparedness and response purposes for an anthrax emergency.

It applies to both doxycycline monohydrate and doxycycline hyclate tablets and capsules equivalent to 50 mg and 100 mg of doxycycline that are indicated for post-exposure prophylaxis or treatment of inhalational anthrax. The guidance and any resulting expiration date extensions authorized by FDA do not apply to doxycycline available commercially or otherwise held for any non-emergency purpose.

Covered in the document are an Introduction, Background, Discussion, and References.

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