FDA Policy/General

Embryll Marketing Unapproved Animal Drug: FDA

FDA says its review of a Web site maintained by Embryll Life Sciences in Middletown, DE, determined that the firm is marketing Lanomax, an unapproved new animal drug product to treat cataracts in animals. A 10/4 Warning Letter says the product is an adulterated unapproved new animal drug and introducing or delivering it for introduction into interstate commerce is illegal.

There currently are no FDA-approved eye drops for use in animals that are labeled for treating, preventing, mitigating, or curing cataracts, FDA says. The agency says Lanomax has not been determined by it to be safe and effective. “Your unproven treatment could cause animal owners to forgo or delay appropriate veterinary care,” the letter says.

The letter gives examples from the firm’s Web site that demonstrate that Lanomax is intended for use to diagnose, cure, mitigate, treat, or prevent disease in animals.

Embryll was told to respond with a list of specific steps it has taken to address any violations with copies of 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