Drugs

Restrict ANDAs for Generic Zoryve: Arcutis

Arcutis Biotherapeutics, Inc., is petitioning FDA not to approve any ANDA for a generic form of the company’s Zoryve (roflumilast) topical cream, 0.3%, that does not take steps dictated by Arcutis to demonstrate that the proposed generic is equivalent to Zoryve. The petition says Zoryve is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients age six and older.

According to Arcutis, Zoryve cream contains roflumilast, a PDE-4 inhibitor, as the active ingredient, and has a novel topical formulation that includes two excipients the company believes are essential to its safety and effectiveness. The petition identifies them as Transcutol (diethylene glycol monoethyl ether), a solvent, and Crodafos CES (ceteareth-10 phosphate, cetearyl phosphate, cetostearyl alcohol), an emulsifier.

“Working together,” the petition says, “these ingredients can be expected to improve safety (primarily centrally mediated gastrointestinal adverse events and psychiatric adverse events) by reducing the rate of systemic absorption and peak-to-trough ratio, while also increasing local absorption and retention at the site of action, thereby potentially contributing to effectiveness.”

Arcutis calls on the agency to

refuse to approve any ANDA for which Zoryve is the reference-listed drug unless the proposed generic product is Q1/Q2/Q3 the same as Zoryve cream, having the same inactive ingredients in the same concentrations and having the same physicochemical and structural properties and showing bioequivalence through appropriate in vitro studies, or the application contains information specified in the petition; and
issue a product-specific bioequivalence guidance for roflumilast topical cream that recommends studies consistent with those requested in the petition.

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