Drugs

Keep Safety and Dosing Info in Valtoco Label: Petition

Neurelis, the NDA holder for Valtoco (diazepam) nasal spray, indicated for the acute treatment of intermittent stereotypic episodes of frequent seizure activity in patients with epilepsy aged 6 years and older, that was later expanded through an sNDA to aged 2 and older, is asking FDA to ensure that applicants seeking to market generic forms of Valtoco are not permitted to carve out critical safety and dosing information in an attempt to circumvent the regulatory exclusivity protections afforded to Neurelis through the Waxman-Hatch Act.

The company’s 7/10 petition says FDA has circulated a proposed model generic label for generic diazepam nasal spray that removes information about new patient population (NPP) exclusivity, including information related to the protected 2- to 5-year-old population. “The model label proposes to omit critical information for the remaining, nonprotected conditions of use, while also improperly retaining Neurelis’ proprietary trademark Valtoco and other protected information in a manner that would induce prescribers to prescribe the generic for the carved-out pediatric use,” the petition says. Neurelis says it understands that one or more generic applicants have submitted or intend to submit an amended marketing statement seeking to carve out the 2- to 5-year-old indication protected by NPP based on the model label. It says that such a carve-out would have the effect of removing critical safety information and therefore should not be permitted.

Neurelis makes these points:

omission of dosage instructions for patients 2 to 5 years old and related pharmacokinetic information would render generic products less safe than Valtoco for the remaining conditions of use;
the proposed FDA model label would not be sufficient to mitigate the risks due to lack of critical information; and
failure to include the 2- to 5-year-old patient population delays the use of intranasal diazepam until 6 years of age.

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