Drugs

AZ Wants Crestor ANDA Restrictions

AstraZeneca is petitioning FDA to not approve any ANDA or 505(b)(2) NDA referencing its Crestor (rosuvastatin calcium) until expiration of the orphan drug exclusivity for using the drug to treat pediatric patients ages 7 to 17 with homozygous familial hypercholesterolemia (HoFH) The petition says that pediatric HoFH is an extremely serious condition that, if left untreated, causes substantially elevated plasma cholesterol levels, which then lead to cardiovascular disease, heart attack, and premature death.

The company lists two reasons why the petition should be approved. First, it says, carving out AstraZeneca’s protected pediatric HoFH labeling from the labeling of a product marketed under an ANDA or 505(b)(2) NDA would present substantial safety and efficacy risks. A carve-out is inappropriate in this condition, it says, because the protected pediatric labeling is necessary for the safe use of the drug. Given the differences in doses and course of treatment for adult and pediatric patients, the petition says, “there are substantial risks that doctors would over- or under-treat pediatric HoFH patients if generic or other rosuvastatin calcium omitted the protected pediatric HoFH labeling.”

Also, the company says, FDA lacks legal authority to carve out pediatric labeling protected by orphan drug exclusivity. It says that the Waxman-Hatch Act same-labeling requirement and FDA’s pediatric labeling regulations together impose a categorical rule that pediatric labeling information subject to orphan drug exclusivity may not be omitted from generic drug labeling.

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