Drugs

Court Backs FDA in MiraLax OTC Decision

The DC Circuit Court of Appeals has ruled that FDA acted properly in denying a request for a hearing and withdrawing an ANDA submitted by Breckenridge Pharmaceutical and Nexgen Pharma for a generic version of Braintree Laboratories’ prescription MiraLax. The court opinion noted that after FDA approved Braintree’s NDA for prescription MiraLax, it later approved that company’s NDA for an over-the-counter version,

The agency told Breckenridge and Nexgen that its approval of the over-the-counter version meant that the drug no longer met the criteria for a prescription drug unless there was a “meaningful difference” between the prescription and over-the-counter versions. The suit challenged FDA’s determination that no meaningful difference exists.

The court said that the agency found that on each of the factors pertinent to a meaningful difference, OTC and Rx MiraLax were identical or nearly so. “We conclude that FDA’s determination that prescription MiraLax is misbranded for lack of a ‘meaningful difference’ with OTC MiraLax is neither arbitrary or capricious,” the three-judge panel said.

The court also rejected the petitioners’ process-based challenges to FDA’s denial of a hearing on withdrawal of prescription MiraLax.

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