Drugs

Mylan Petitions FDA for Strict Bioequivalence on Advair Generics

Mylan has petitioned FDA to require specific bioequivalence study designs for ANDA applicants seeking to market generic versions of GlaxoSmithKline’s asthma therapy Advair Diskus (fluticasone propionate and salmeterol xinafoate) inhalation powder. The Mylan petition asks FDA to refrain from approving any ANDA that “relies on multiple-batch pharmacokinetic (PK) bioequivalence (BE) study designs unless, after conducting an appropriately rigorous review under the established standards for establishing BE, generally, and for this product specifically, FDA concludes that such a study design is valid and will ensure patients receive a robust and reliable therapeutically equivalent product.”

The petition acknowledges that Mylan has already filed an ANDA referencing Advair Diskus. It says based on its development work, “we know that a sponsor need not turn to unvalidated alternative methods as it is possible, with an adequate understanding of the RLD [reference-listed drug] and a well-designed proposed generic, to demonstrate BE using straightforward and established single-batch BE studies designed in accordance with FDA’s guidance, experience, and precedent.”

Mylan says it is concerned that “applicants may be attempting to rely on novel, unprecedented PK/BE study designs to support bioequivalence of a proposed product to the RLD because they have not adequately performed the necessary development work to understand the RLD product and the proposed generic and, as a result, are unable to demonstrate PK BE using accepted methods as provided by the guidance. Such an unprecedented design has not been demonstrated to constitute valid, reliable data that could support ANDA approval, and sponsors who have failed to show BE using more straightforward and well-established methods should not be permitted to take failed studies and attempt to instill them with meaning using an atypical multiple-batch study design — specially when the more straightforward, well-understood design provided for in the guidance is sufficient to establish BE.”

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