buphenyl

buphenyl

An orphan drug for managing urea cycle disorders—e.g., deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase, or argininosuccinic acid synthetase—and indicated for infants with neonatal-onset deficiencies presenting within the first 28 days of life, in whom episodes of acute hyperammonemic encephalopathy are often fatal, and when not, often result in profound mental retardation.

Adverse effects
Amenorrhoea, anorexia, body odour due to phenylacetate excess, abdominal pain, nausea, arrhythmias, renal tubular acidosis, rash, headaches, syncope, weight gain, metabolic acidosis, increased alkaline phosphatase, anaemia.
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Currently, Sigmapharm's product line consists of Adefovir Dipivoxil Tablets, for hepatitis B, which is the first and only generic product equivalent to Hepsera tablets; Sodium Phenylbutyrate Powder, for urea cycle disorders, which is equivalent to Buphenyl powder; Acitretin Capsules, which is equivalent to Soriatane capsules, with a primary indication for the treatment of severe psoriasis; and Liothyronine Sodium Tablets, for hypothyroidism, which is the most stable Liothyronine product on the market, with a recently Food and Drug Administration-approved shelf life of five years.
The deal increases the number of Horizon's products from five to seven, with the addition of Ravicti and Buphenyl to Horizon's orphan business unit, providing additional revenue diversification
It owns worldwide rights to BUPHENYL (sodium phenylbutyrate) Tablets and Powder in the US.
The prescription medication is Buphenyl, which is sodium phenylbutyrate.
Her test tube studies suggest that a drug called buphenyl could guide the protein to where it belongs.
That acquisition added two rare-disease drugs that treat urea cycle disorders, Ravicti and Buphenyl, to Horizon's portfolio.
According to the company, Ravicti, an investigational drug, is a pre-pro-drug of phenylacetic acid, the active moiety of BUPHENYL, the only branded therapy currently FDA-approved as adjunctive therapy for the chronic management of patients with the most prevalent urea cycle disorders.
Currently, Sigmapharm's product line consists of Adefovir Dipivoxil Tablets, for hepatitis B, which is the first and only generic product equivalent to Hepsera tablets; Sodium Phenylbutyrate Powder, for urea cycle disorders, which is equivalent to Buphenyl powder; Liothyronine Sodium Tablets, for hypothyroidism, which is the most stable liothyronine product on the market, with a shelf life of 36 months and soon to be 48 months; and Acitretin Capsules (AB-rated to Soriatane capsules), with a primary indication for the treatment of severe psoriasis.
5m was collected from the sale of RAVICTI and BUPHENYL for the third quarter of 2013.
The 4-week, multi-center, randomised, double-blind, cross-over, Phase III study, conducted in adults with urea cycle disorders, was designed to evaluate the non-inferiority of glycerol phenylbutyrate to BUPHENYL
Other Sigmapharm releases include Liothyronine Sodium Tablets, for hypothyroidism, which is the most stable Liothyronine product on the market with a shelf life of 36 months; Adefovir Dipivoxil Tablets, for hepatitis B, which is the first and only generic product equivalent to Hepsera Tablets; and Sodium Phenylbutyrate Powder, for urea cycle disorders, which is the first and only generic product equivalent to Buphenyl Powder.
M2 EQUITYBITES-May 3, 2013-Hyperion Therapeutics Inc exercises option to acquire the BUPHENYL and AMMONUL rignts(C)2013 M2 COMMUNICATIONS http://www.