Drugs

Sandoz Seeks Stricter Advair Bioequivalence in ANDAs

Sandoz has petitioned FDA asking that it not 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 says 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 “However, to the extent that these ANDA applicants relied solely on FDA’s draft guidance in conducting their PK bioequivalence studies, Sandoz is concerned that the applications may fail to contain accurate and generalizable evidence of PK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:

(1) Type 1 error rate is adequately controlled in PK bioequivalence testing, including accounting for Type I error rate inflation caused by batch-to-batch variability of the RLD;

(2) the dose used in PK bioequivalence testing retains the necessary sensitivity to product differences existing at the marketed single inhalation dose of the RLD; and

(3) the sampling schedule used in PK bioequivalence testing is robust and centered around the actual time to maximum plasma concentration of both active ingredients at the marketed dose of the RLD.

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