Drugs

FDA Denies Without Comment AZ Falsodex Petition

To meet a statutory time deadline, FDA has denied a 5/15 AstraZeneca petition asking for specific agency action involving the company’s Falsodex (fulvestrant) intramuscular (IM) injection without commenting on whether it will ultimately take the requested actions. The AstraZeneca petition cited a Teva 505(b)(2) NDA referencing Falsodex and indicated that AZ had learned that Teva would omit benzyl benzoate from its formulation and that presumably other excipients in the proposed product would be substituted or changed. The actions sought by AZ were:

refrain from approving the Teva application unless specific requirements are met in the proposed product;
refrain from designating the proposed product as therapeutically equivalent to Falsodex IM injection; and
take the actions in the first two points with respect to any other 505(b)(2) application citing Falsodex IM injection as the reference-listed drug and proposes a drug product claimed to have a different formulation.

The FDA denial letter says that by law, FDA must respond to the petition within 150 days. Since the agency must take action at this time, it says, it is denying without comment the specific requests in the petition about the approvability of any specific 505(b)(2) application.

FDA says it has made no final determination on whether to approve or not approve any 505(b)(2) NDA of the type described in the petition for fulvestrant injection that cites Falsodex IM injection as the listed drug relied upon and that proposes a drug product claiming to have a different formulation from Falsodex IM injection. It further says that Congress did not intend to require FDA to make a final decision within the statutory deadline on the approvability of a specific aspect of an application when a final decision on the approvability of any such application has not yet been made.

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