Drugs

FDA Now Says Stribild Eligible for 5-Year NCE Exclusivity

FDA says that to minimize the possibility of further legal challenge, it has determined that in accordance with the DC federal court holding in Ferring Pharmaceuticals v. Burwell, Gilead’s Stribild (cobicistat; elvitegravir; tenofovir disoproxil fumarate) is eligible for five-year new chemical entity (NCE) exclusivity because it contains cobicistat and elvitegravir, two active ingredients not present in any NDA approved by FDA before the NDA approval for Stribild. Stribild is a fixed-combination drug product that at the time of its 2012 approval was denied five-year exclusivity and granted three-year exclusivity because of agency policy interpretations at that time.

In its petition response, FDA said that by previous agency action it had granted Gilead’s requests that it:

determine that Stribild is eligible for five-year NCE exclusivity;
extend five-year exclusivity under the agency’s “umbrella policy” to drug products containing cobicistat and elvitegravir, specifically Tybost (cobicistat) and Vitekta (elvitegravir); and
withdraw receipt of any ANDA received by FDA before 8/27/16 that references a drug containing elvitegravir or cobicistat as a reference-listed drug, including Mylan’s ANDA that names Tybost as the reference-listed drug.

The letter says the exclusivity period for Stribild and the drugs covered under the umbrella policy expires 8/27.

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