Drugs

Kirkman Marketing Unapproved New Drugs

A 6/3-6/24/15 FDA inspection at the Kirkman Laboratories drug manufacturing facility in Lake Oswego, OR, found that the company is marketing four unapproved new drugs, according to a 1/13 Warning Letter from the agency’s Seattle District Office. The document lists both unapproved new drug violations and misbranding violations.

It says that the four products are intended for use in diagnosing, curing, mitigating, treating, or preventing disease in humans and are not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in their labeling. It also says that the products are considered to be prescription drugs because, in light of their toxicity or potential for harmful effects, or the method of their use, or the collateral measures necessary for their use, they are not safe to use except under the supervision of a practitioner licensed to administer them.

In addition, the letter says, because the drug products are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written for them so that a layperson can use them safely for their intended uses.

Kirkman was told to take prompt action to correct the violations and to respond with a list of steps taken or to be taken to correct the violations and prevent their recurrence and a timetable for completion.

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