Drugs

FDA Denies Millennium Velcade Petition

FDA has denied a 6/9 petition submitted by Millennial Pharmaceuticals asking that FDA:

not approve any ANDA or 505(b)(2) bortezomib product for any multiple myeloma indication with labeling that omits information on the safe and effective conditions of use for the treatment of relapsed patients;
not approve any ANDA or 505(b)(2) bortezomib product for any mantle cell lymphoma indication with labeling that omits information on the safe and effective conditions of use for treatment in previously untreated patients or labeling that adds new language to modify Millennial’s Velcade for injection current mantle cell lymphoma indication;
seek public comment if FDA is considering allowing an ANDA applicant to revise Velcade’s current mantle cell lymphoma indication by adding new language, consistent with FDA’s prior action in similar situations;
identify the Velcade active ingredient as the mannitol ester of bortezomib;
require Fresenius’ 505(b)(2) application for an injectable bortezomib formulation containing boric acid to be supported with data specified by Millennial; and
require the Fresenius 505(b)(2) application to identify each source of information relied on to support approval of its application, including any previous approved product relied on through FDA’s inactive ingredient database.

The denial letter says FDA disagrees with the petition’s assertion that omitting protected information would adversely affect the efficacy of ANDA and 505(b)(2) bortezomib drug products for treating multiple myeloma patients. The agency also says it disagrees with the petition’s assertion about the identification of Velcade’s active ingredient and disagrees with the petition’s position on the Fresenius application.

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

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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