FDA Policy/General

Generic Adspec Approved for Bovine Pneumonia

FDA has approved Bimeda Animal Health’s SpectoGard (spectinomycin sulfate), the first generic copy of Pharmacia Animal Health’s Adspec for treating bovine respiratory disease associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.

An FDA news release warns that allergic reactions may occur in previously sensitized individuals. “Repeated or prolonged exposure may lead to sensitization,” it says. “Direct contact with skin, eyes, mouth, and clothing should be avoided. People with a known hypersensitivity to spectinomycin should avoid exposure to this product.”

The generic product is supplied in 500mL vials and should be administered to cattle at a daily dose of 10 to 15 mg spectinomycin per kg of body weight in 24-hour intervals for three to five consecutive days.

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