Drugs

Novid Distributing Unapproved, Misbranded Drug: FDA

FDA says Novid Group in Northridge, CA, is distributing an over-the-counter combination antihistamine and nasal decongestant, novid Nasal Spray, through its Web site. A 12/7 Warning Letter says the product is illegally distributed because it is an unapproved new drug that also is misbranded.

The letter contains claims from the company Web site that provide evidence of the product’s intended use as a drug to diagnose, cure, mitigate, treat, or prevent disease.

According to FDA, the novid product is not formulated or labeled according to the requirements in the applicable over-the-counter drug monograph.

The product is misbranded, the letter says, because it is a nonprescription drug that does not comply with the requirements for marketing under the Federal Food, Drug, and Cosmetic Act.

Novid Group was told to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence, with related documentation and a schedule for completing the corrections.

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