Drugs

Don’t Approve Vasostrict Dosing Changes: Petition

Attorney Scott Lassman has petitioned FDA to refuse to approve proposed dosing modifications sought by Par Sterile Products for its Vasostrict (vasopressin injection) based on patient genotype. The 1/29 petition says the Par request should be denied “in the absence of rigorous and convincing clinical evidence, including evidence from one or more adequate and well-controlled clinical studies, demonstrating that the proposed labeling changes are appropriate and necessary to support the safe and effective use of Vasostrict.”

The petition says it appears that Par submitted its sNDA not because there is a real clinical need to improve the safe or effective use of vasopressin in the hospital setting, but rather as an anti-competitive, “evergreening” tactic to delay or block impending generic competition. It says the evidence supporting the change appears to be an ad hoc analysis of a small pharmacokinetic (PK) study in 41 healthy volunteers without any scientific evidence demonstrating that the PK results, even if valid, have any clinical significance.

Specifically, the petition asks that FDA:

refuse to approve changes to the dosing instructions for Vasostrict based on pharmacogenomic information in the absence of:

o a clearly defined clinical need for such dosing modifications;

o rigorous scientific evidence demonstrating that there are statistically significant differences in vasopressin clearance and steady-state concentration based on a patient’s leucyl/cystinyl aminopeptidase rs4869371 genotype;

o rigorous scientific evidence, including evidence from one or more prospective, randomized controlled trials demonstrating that the above-described PK differences, if any, are clinically significant; and

o a demonstration that the proposed labeling changes based on genotype differences have clinical relevance and utility and are actionable by healthcare professionals in the acute care setting in which Vasostrict is administered; and

provide the petition to CDER reviewers responsible for assessing, providing recommendations on, and/or taking action on Par’s sNDA.

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

Read more

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