Drugs

Silvergate Wants Epaned BE Requirements

Silvergate Pharmaceuticals is asking FDA to impose specific bioequivalence (BE) requirements on any ANDA citing its antihypertensive Epaned (enalapril maleate) oral solution 1 mg/mL as the reference-listed drug. The company asks that any such ANDA not be approved unless it contains sufficient evidence data to establish in vivo bioequivalence. It asks the agency to:

require all applicants submitting an ANDA referencing Epaned to conduct in vivo bioequivalence tests and studies comparing the proposed generic product to Epaned;
refrain from granting any in vivo bioequivalence waiver for any ANDA referencing Epaned;
refuse to approve any ANDA for a proposed generic that is not qualitatively and quantitatively the same as Epaned unless the application includes BE studies with pharmacokinetic endpoints conducted under both fed and fasted conditions demonstrating that the systemic absorption of the active enalaprilat from the proposed generic is the same as Epaned; and
require that the results of such tests and studies establish the in vivo bioequivalence of any generic Epaned product sufficient to permit final approval of any such ANDA under FDA regulations.

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