Drugs

CDER Denies Oxtellar BE Petition

CDER has denied an 8/3/15 Supernus Pharmaceuticals petition asking that the agency require specific partial area under the plasma concentration-time curve bioequivalence parameters to govern the review and approval of any ANDA referencing Oxtellar XR (oxcarbazepine) as the reference-listed drug. The denial letter says that while the Center agrees with the company that changes in the formulation of a generic oxcarbazepine extended-release product may result in different pharmacokinetic (PK) profiles, it does not agree that differences in the PK profile for generic versions of tablets demonstrated to be bioequivalent to Oxtellar XR in accordance with FDA’s draft oxcarbazepine guidance would have a clinically meaningful impact on the drug’s safety and efficacy.

It also said that in preparing its response to the petition, the Center conducted simulations of four separate hypothetical test formulations of extended-release oxcarbazepine with different release or absorption rates based on the PK and pharmacodynamics models in the Oxtellar XR NDA submission. “These simulations indicated that the four hypothetical test formulations would be considered bioequivalent to Oxtellar XR under FDA’s traditional PK metrics, but would not be considered bioequivalent under the partial AUC metrics proposed by petitioner. These simulations further suggested that despite having different PK profiles, these four hypothetical test formulations would be associated with similar efficacy responses … and safety responses…. As a result, these simulations support FDA’s position that generic oxcarbazepine extended-release products that are considered bioequivalent to Oxtellar XR … can be expected to have the same therapeutic effect as Oxtellar XR, notwithstanding any difference in PK profiles.”

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