Drugs

Hua Da Trading Selling Unapproved Viagra: FDA

FDA says its review of a Web site maintained by Hua Da Trading in Brooklyn, NY, determined the firm takes orders for its “WeFun” product which is considered by FDA to be an unapproved and misbranded drug, even though the firm markets it as a dietary supplement. A 12/20/2023 Warning Letter says a laboratory analysis of a sample of WeFun confirmed that it contains the undeclared pharmaceutical ingredient sildenafil, the active ingredient in Viagra, used to treat erectile dysfunction.

The letter says that although the product’s labeling indicates it is a dietary supplement, supplements may not include an article that is approved as a new drug. “Given that sildenafil was not marketed as a dietary supplement or as food before Viagra was approved, your “WeFun” product is excluded from the definition of dietary supplement…,” FDA says.

The letter says that in addition to being an unapproved drug, WeFun is misbranded because it does not contain adequate directions for use, because its labeling is false or misleading, and the labeling lacks adequate warnings for the protection of users.

In the letter, FDA also expressed concern about several other Hua Da products that may contain sildenafil or tadalafil, the active ingredient in Cialis.

The company was told to respond with a list of specific actions it has taken to address any violations and prevent their recurrence, with documentation of the actions.

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