letter about safety violations in september 2007. in 2010 the fda rejected jazz' new drug application for use of sodium oxybate in fibromyalgia. in october 2011, the fda sent jazz another fda warning letter for failing to collect, evaluate, and promptly report adverse effects to the fda after it started marketing the drug. it sent another letter in 2013 saying that the problems described in the 2011 letter appeared to be resolved. in january 2017 the fda approved the first generic sodium oxybate product for narcolepsy symptoms, which is also subject to the same rems program conditions as the original. by april 2017 seven companies had filed abbreviated new drug applications (andas) with the fda to market generic versions of xyrem and jazz had filed patent infringement cases against them. hikma pharmaceuticals had been the first company to file an anda and jazz settled with them in april 2017; under the agreement hikma could begin selling an authorized generic in 2023 under jazz' rems, and would have five years of exclusivity, however, those conditions could change if jazz' patents were invalidated. in 2017, jazz and valeant terminated the agreement under which valeant marketed xyrem in canada. in 2023, jazz licensed the right to produce an authorized generic of xyrem to hikma pharmaceuticals, marketed as sodium oxybate oral solution." society and culture regulation in the us, ghb is a schedule i controlled substance, while sodium oxybate, when used under an fda nda or ind application, is classified as a schedule iii controlled substance for medicinal use under the controlled substances act, with illicit use subject to schedule i penalties. in canada and the european union (eu), as of 2009 it was classified as a schedule iii and a schedule iv controlled substance, respectively. cost in the us, the cost (as of q3 2015) of xyrem is $5,468.09 per 180 ml bottle (500 mg/ml)(a 10 to 15-day supply) as of 2017 the cost of sodium oxybate in the uk was £540.00 to £1,080.00 for a thirty-day supply, which at typical doses is £6,500 to £13,100 per year. jazz pharmaceuticals raised the price of xyrem 841% earning a total of $569 million in 2013 and representing more than 50% of jazz pharmaceutical's revenues. in 2007 it cost $2.04; by 2014 it cost $19.40 per 1-milliliter dose. jazz offers copay assistance to help patients access the expensive drug. according to drx, a drug-data report published by bloomberg, jazz pharmaceuticals price increase on xyrem topped the list of price hikes in 2014. historically, orphan drugs cost more than other drugs and have received special treatment since the enactment of the us orphan drug act of 1983. however, these steep price increases of orphan and other specialty drugs has come under scrutiny. the average cost of a specialty drug in the us was $65,000 annually in june 2013 (about $5,416 a month). the price of xyrem in the us has inflated by an average of 40% annually since it became available as a prescription. the first authorized generic sodium oxybate, produced by hikma pharmaceuticals, was made available in january of 2023. in european union (eu) countries, the government either provides national health insurance (as in the uk and italy) or strictly regulates quasi-private social insurance funds (as in germany, france, and the netherlands). these government agencies are the sole purchaser (or regulator) of medical goods and services and have the power to set prices. the cost of pharmaceuticals, including sodium oxybate, tends to be lower in these countries. nhs england authorises and pays for sodium oxybate by means of individual funding requests on the basis of exceptional circumstances. the british department of health pays for the medication for 80 patients who are taking legal action over problems linked to the use of the swine flu vaccine pandemrix at a cost of £12,000 a year. as of 2016 there were many areas in the uk where nhs did not pay for it. in may 2016 they were ordered by the high court to provide funding to treat a teenager with severe narcolepsy. the judge criticised their "thoroughly bad decision" and "absurd" policy discriminating against the girl when hundreds of other nhs patients already receive the drug. names sodium oxybate is the common name for the chemical; it has no international nonproprietary name (inn). as of april 2018 sodium oxybate was sold under the following brands: alcover (italy), gamma-oh (france), natrii oxybutyras kalceks (latvia), somsanit (germany), xyrem (many countries by jazz and ucb). in 2023, the first authorized generic of xyrem was made available in the u.s.. research sodium oxybate needs to be given during the night; as of 2017 research was ongoing to create formulations that would last through the night. jazz has been developing jzp-386, a deuterated analog of sodium oxybate. the company presented phase i results in 2015, stating that deuterium-related effects made it necessary to do further formulation work as part of the drug's development.