Eton’s NDA for Zonisamide accepted by FDA

The application was submitted for the treatment of partial seizures in patients with epilepsy. 

Zonisamide is one of Eton’s three neurology-focused oral liquid product candidates that have been submitted to the FDA, and all three product candidates are expected to be approved and launched in 2021.

FDA accepts Eton NDA for dehydrated alcohol injection

Eton’s application previously received orphan drug designation for the treatment of methanol poisoning and is expected to receive seven years of market exclusivity upon its approval.

The company currently owns or receives royalties from three FDA-approved approved products, including ALKINDI SPRINKLE, Biorphen, and Alaway Preservative Free, and has six additional products in its late-stage pipeline, including five that have been submitted to the FDA.

The U.S. market for dehydrated alcohol injection is estimated to be greater than $100 million annually and the drug is currently only supplied by a single manufacturer.

Eton submits NDA for dehydrated alcohol injection to the FDA

Eton’s DS-100 has been granted orphan drug designation for the treatment of methanol poisoning, and as a result, the product is expected to receive seven years of market exclusivity upon its approval. The incidence of methanol poisoning has increased significantly in 2020 due to *redacted*, as unprecedented demand for hand sanitizers has led some manufacturers to improperly use methanol in their products. Earlier this month, the FDA recommended manufacturers recall more than 75 different hand sanitizers that were found to contain methanol despite being labeled as ethanol. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin or ingested. The FDA has reported cases of adults and children suffering from adverse events including blindness, hospitalization and death, due to methanol poisoning caused by methanol-based sanitizers.

 The DS-100 NDA represents Eton’s second orphan drug candidate and fifth total drug candidate under review with the FDA. Alkindi Sprinkle, the company’s other orphan drug product, is currently under FDA review as a replacement therapy for pediatric adrenal insufficiency (AI) and has been assigned a PDUFA date of 9/29/2020. Eton’s EM-100 (preservative-free ketotifen ophthalmic solution) product candidate has a target action date of 8/10/2020.