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Find Clinical Drug Pipeline Developments & Deals by Eton Pharmaceuticals
ET-400 is Eton’s proprietary patented formulation of hydrocortisone oral solution. Company has submitted NDA for ET-400 use in endocrine system disorders.
Through the acquisition, Eton gains access to an abbreviated new drug application for Nitisinone Capsules via Oakrum. Nitisinone is FDA approved or the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.
FDA issued a Complete Response Letter (CRL) in response to its New Drug Application (NDA) for dehydrated alcohol injection for the treatment of methanol poisoning.
Betaine anhydrous for oral solution is indicated in children and adults for the treatment of homocystinuria to decrease high homocysteine blood levels. The program will provide prescription fulfillment, insurance benefits investigation, educational support.
Through the acquisition, Eton will expand its portfolio with ET-600 which is an innovative product candidate under development for the treatment of an endocrinology condition.
USFDA has accepted for review the company’s NDA response for dehydrated alcohol injection (a nerve blocking agent) for the proposed indication of methanol poisoning.
Betaine shares the same prescriber base as the carglumic acid tablets, so it is an attractive opportunity to leverage the existing commercial infrastructure.
Zonisade is the first and only zonisamide formulation for oral liquid administration to be approved by the US Food and Drug Administration as an adjunctive therapy for the treatment of partial seizures in adults and paediatric patients aged 16 years and older with epilepsy.
Under terms of the agreement, Dr Reddy’s purchased the Biorphen® (phenylephrine hydrochloride), Rezipres®, and Cysteine Hydrochloride products. Dr Reddy’s will immediately take ownership of Eton’s rights and interests in the products.
U.S.FDA granted company,180 days of generic exclusivity as a result of being the first ANDA submitted for cysteine hydrochloride injection, a bioequivalent generic of Exela Pharma Sciences’ Elcys, against the reference product.