Drugs

Almirall’s Seysara Label Update on Resistance

FDA has approved a label update for Almirall’s Seysara (sarecycline) stating that P. acnes strains displayed a low propensity for developing resistance to sarecycline. This information is included in the Microbiology Section (12.4) of the prescribing information, the company says. Seysara, which was approved 10/2018, is described as a novel tetracycline-derived oral antibiotic developed specifically for treating acne. It is indicated for treating inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients nine years of age and older.

Almirall says the label update is based on data that demonstrated that P. acnes strains display low propensity for developing resistance to sarecycline, with spontaneous mutation frequencies being about 1 in 10 billion at four to eight times the minimum inhibitory concentration. This means that the main bacterium associated with acne has shown a very low potential of developing resistance to sarecycline, it says.

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

Read more

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