Drugs

WHO Looking for Alternate Levonorgestrel API Sources

The World Health Organization (WHO) says it is working with finished pharmaceutical product manufacturers to identify additional sources for levonorgestrel following an FDA 3/8 import alert on Qinhuangdao Zizhu Pharmaceutical in Hebei, China. In its response to the import alert, WHO says that FDA investigators found failures in the level of adherence to cGMP for active pharmaceutical ingredients, particularly a breach of data integrity related to testing in the quality control laboratory.

The response says the WHO has been in touch with the company and with FDA to discuss the matter. “At the moment, there is no alternative levonorgestrel API which has been prequalified by the WHO prequalification team,” it says.

Manufacturers of prequalified products that use levonorgestrel manufactured by Qinhuangdao Zizhu were asked by WHO to take additional measures such as comprehensive testing upon receipt to help ensure that the quality of all batches of levonorgestrel is assured.

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