Drugs

FDA Approves 8 Generic Crestor ANDAs After Denying Petition

FDA approved 7/19 eight generic copies (see approval letters below) of AstraZeneca’s cholesterol-lowering Crestor (rosuvastatin), the same day it rejected the company’s citizen petition seeking a delay on ANDA final approvals (see earlier story). The petition sought a block on any rosuvastatin ANDAs that contained a labeling “carve-out” omitting marketing exclusivity-protected pediatric labeling. “FDA does not believe that carving out the orphan-protected pediatric HoFH indication would present a safety risk to pediatric patients with HoFH and concludes that a 505(b)(2) NDA or ANDA referencing Crestor that does not include the orphan-protected information in its labeling is safe and effective for the remaining non-protected conditions of use,” the agency said in its denial letter. “As a scientific matter, FDA concludes that Crestor’s labeling information for adults with HoFH is not significantly different from its labeling for pediatric patients with HoFH. Generic approvals were granted to the following companies:

Apotex Approval Letter
Mylan Approval Letter
Teva Approval Letter
Par Approval Letter
Sun Approval Letter
Aurobindo Approval Letter
Sandoz Approval Letter
Glenmark Approval Letter

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