Drugs

AZ Wants Restrictions on Applications Citing Faslodex

AstraZeneca says that FDA should not approve a Teva 505(b)(2) application referencing Faslodex (fulvestrant) intramuscular injection as the listed drug and that proposes a drug product asserted to have a different formulation unless certain conditions are met. The AstraZeneca petition says FDA should require that:

the application contain data showing that the purportedly different formulation does not render the proposed product unsafe, including (1) clinical data demonstrating safety and efficacy with respect to the risks of tissue damage and pain at the injection site; and (2) if the proposed product contains any inactive ingredient in an amount higher than that established to be safe for repeated intramuscular administration over an extended period of time, data from toxicity testing showing that the proposed product does not present safety concerns; and
the application contain appropriate bridging ceremonies, including data from a study comparing the proposed product’s bioavailability to that of Faslodex IM injection at multiple-dose steady state, to provide an adequate basis for reliance upon FDA’s finding that Faslodex IM injection is safe and effective.

The company also asks that FDA not designate the proposed Teva product as therapeutically equivalent to Faslodex IM injection unless certain specified conditions are met, and that the agency take the same actions with respect to any other 505(b)(2) application that claims Faslodex IM injection as the listed drug and proposes a drug product claimed to have a different formulation.

“The unique properties of fulvestrant and intramuscular injections make the specific data identified in this petition necessary as a public health matter,” AstraZeneca says.

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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’

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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