Drugs

Vanda Wants Restriction on Generic Fanapt

Vanda Pharmaceuticals is asking FDA not to approve an ANDA referencing its Fanapt (iloperidone) until expiration of the three-year exclusivity covering changes made to the Fanapt labeling for which the company says that a clinical study relating to maintenance treatment was essential. Fanapt is approved for treating schizophrenia in adults. The petition says that FDA conditioned approval on a post-marketing commitment to study the drug for maintenance treatment.

Vanda says it satisfied its commitment through the REPRIEVE study that demonstrated that Fanept is more effective than placebo in preventing or delaying relapse when administered for longer than six weeks.

“REPRIEVE thus provided valuable new information about the use of Fanapt for treating schizophrenia,” the petition says. “FDA recently granted three-year exclusivity to Fanapt for labeling changes resulting from REPRIEVE findings.” It says that because the study was essential to the approval of labeling changes adding information about maintenance treatment and removing the previous limited information about maintenance treatment, both are protected by three-year exclusivity and it is not possible for generic products to bear approvable labeling.

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