Drugs

Deny PMRS RoxyBond Petition Quickly: Daiichi

Daiichi Sankyo says that FDA should deny without delay a Pharmaceutical Manufacturing Research Services (PMRS) petition calling for the agency to stay the effective date for the 4/20 approval of Daiichi’s RoxyBond (oxycodone hydrochloride) immediate-release tablets submitted by Inspirion Delivery Sciences. The Daiichi response says the PMRS petition “lacks scientific merit or a legitimate legal or policy basis.”

According to Daiichi, FDA should deny the PMRS petition because the agency correctly and reasonably approved RoxyBond and its labeling under applicable statutory and regulatory standards for drug approval. “FDA properly based its decision on robust scientific and clinical data consistent with FDA’s abuse-deterrent framework,” the response says, “and the PMRS petition does not otherwise meet the applicable standards or grounds” under regulations.

FDA can grant a petition to stay only if four criteria are met, Daiichi says, arguing that the PMRS petition does not satisfy any one factor, let alone all four. The factors are:

the delay resulting from a stay is not outweighed by public health or other public interests;
the petitioner has demonstrated sound public policy grounds supporting the stay;
· the petitioner’s case is not frivolous and is being pursued in good faith; and
the petitioner will suffer irreparable injury.

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