Drugs

Bausch Hit With OPDP Letter on Duobrii

Bausch Health Companies has received only the second untitled letter from CDER’s Office of Prescription Drug Promotion (OPDP) this year, citing the firm over its promotional communications, a direct-to-consumer video, and an efficacy Web page on its healthcare professional Web site for Duobrii (halobetasol propionate and tazarotene) topical lotion.

OPDP’s first letter was issued 1/19 on an Eli Lilly social media post for Trulicity (dulaglutide) injection because it made “false or misleading claims and representations about the drug’s benefits and risks. That untitled letter said the violations were especially concerning from a public health perspective because the promotional communication created a misleading impression about Trulicity’s safety and effectiveness (see earlier story).

In Bausch’s letter, OPDP says its video and Web page make false or misleading claims or representations about the risks associated with, and the efficacy of, Duobrii. The agency was further troubled by the video’s failure to include information regarding risks associated with Duobrii, such as serious systemic risks and serious skin reactions.

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