Drugs

Petition Seeks Removal of Blocks on Generic Seroquel

A just-filed citizen petition has asked FDA to determine whether the 180-day marketing exclusivity for a Handa ANDA for quetiapine fumerate extended-release tablets has effectively been forfeited for failing to obtain tentative approval within 30 months. It also asks the agency to determine whether Handa is not actively pursuing approval of its ANDA, which could make the approval of subsequent ANDAs immediately effective.

According to the petition, submitted by David Wong as an individual (no further identification supplied), the 180-day exclusivity period was triggered and began on 11/1/2016 when Par Pharmaceuticals, which acquired and controls Handa ANDA 090482, began commercial marketing of an authorized generic of the same drug. Wong says he “seeks to accelerate approval of tentatively approved ANDAs, which were blocked by first-to-file status of Handa ANDA 090482.”

Quetiapine fumerate is the active ingredient in AstraZeneca’s Seroquel, indicated for adults as an add-on treatment to an antidepressant for patients with major depressive disorder. It is also approved for acute depressive episodes in bipolar disorder patients.

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