Drugs

FDA Denies Sandoz Petition on Generic Advair

FDA has denied a 10/2016 Sandoz citizen petition that asked FDA not to approve generic copies of GlaxoSmithKline’s asthma inhaler Advair Diskus 100/50 (fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder) unless ANDA submissions contain data from a pharmacokinetic (PK) bioequivalence study that is stricter than requirements outlined in an agency guidance. Presumably, Sandoz has filed an ANDA seeking approval for a generic Advair Diskus.

The Sandoz petition said it is aware that FDA has accepted for review ANDAs that reference Advair Diskus as the reference-listed drug (RLD). “However, to the extent that these ANDA applicants relied solely on FDA’s draft guidance in conducting their PK bioequivalence studies, Sandoz is concerned that the applications may fail to contain accurate and generalizable evidence of PK bioequivalence for their low-strength (100/50) products. Accordingly, Sandoz requests that FDA refrain from approving any ANDA for a generic version of Advair Diskus 100/50 unless the agency ensures that the Type 1 error rate is adequately controlled in PK bioequivalence testing, among other issues.

In denying the petition without comments, FDA said it has made no final determination on whether to approve or not approve any ANDA referencing Advair Diskus 100/50 as its RLD. “In the case of ANDAs referencing Advair Diskus 100/50, FDA’s consideration of one or more applications will necessarily inform our decisions on the nature of the data and information regarding the approvability of such applications (and also whether any revisions to the draft guidance are appropriate),” the denial letter said.

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