FDA Policy/General

Product Approval Summaries

HUMAN DRUGS

FDA has approved an Allergan NDA for Byvalson (nebivolol and valsartan) 5 mg/80 mg tablets, indicated for treating hypertension to lower blood pressure. The company says the product is the first fixed-dose combination of a beta blocker and angiotensin II receptor blocker available in the U.S.

ANI Pharmaceuticals, Inc. has received approval from FDA for oxcarbazepine tablets, 150mg, 300mg and 600mg. Oxcarbazepine is an antiepileptic drug indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and as monotherapy in the treatment of partial seizures in children aged 4 years and above with epilepsy, and as adjunctive therapy in children aged 2 years and above with partial seizures.

FDA has approved a ViiV Healthcare supplemental NDA for dolutegravir 10mg and 25mg oral tablets, reducing the weight limit from at least 40kg to at least 30kg, in ages six to less than 12 years old, for the treatment of HIV-1 in children and adolescents. Dolutegravir is indicated for treating pediatric patients weighing at least 30kg living with HIV-1 who are treatment naïve and who are treatment experienced, as long as they have not previously taken an integrase inhibitor.

DEVICES

FDA has cleared an Astute Medical 510(k) for the NephroCheck Test Kit that will extend its shelf life from 16 weeks to 12 months when refrigerated. The test is designed to help determine if certain hospitalized patients are at risk of developing moderate to severe acute kidney injury (AKI) in the 12 hours following test administration. “Early knowledge that a patient is likely to develop AKI may prompt closer patient surveillance and help prevent permanent kidney damage or death,” the company says. The extended shelf life will allow labs to maintain larger inventories to support test demand from critical care units, it says.

FDA has cleared a Cereve de novo petition to allow marketing of its Sleep System, a prescription device that the company says is intended to reduce latency to Stage 1 and Stage 2 sleep for people with insomnia. The device was developed based on research at the University of Pittsburgh that confirmed that the frontal cortex, or executive brain, stays active in people with insomnia during sleep, preventing them from getting deeper, more restorative sleep, according to the company. The Sleep System comprises a software-controlled bedside device that cools and pumps fluid to a forehead pad that is worn through the night. Cereve says the device works by gently cooling the forehead within a precise, clinically-proven therapeutic range in order to reduce activity in the frontal cortex.

Endocure Technologies, Inc. has received FDA 510(k) clearance for its Endocure EUR078A Ureteroscope. The company says the device will be manufactured in the U.S. and represents a major step forward in technology and ergonomics.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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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