Sanofi resubmitted the application which the FDA accepted in September 2015, by which time Sanofi had lost the lead in the field of anti-diabetic drugs to Novo Nordisk. Lixisenatide received FDA approval on July 28, 2016.In 2010, Zeland and Sanofi extended their license agreement to allow Sanofi to develop a combination therapy of lixisenatide with insulin glargine, which was Sanofis best selling drug at the time, with sales of around €3 billion in 2009. Sanofi planned to start the Phase III trial that year. Sanofi submitted the NDA in December 2015 for the combination, called LixiLan and it was considered by the same Endocrinologic and Metabolic Drugs Advisory FDA Committee that was considering lixisenatide as a single agent. In May 2016 by a vote of 12–2, with several members of the committee expressing reservations about Sanofis plans to offer two pens with different ratios of insulin glargine and lixisenatide - one for people who had never taken insulin before and one for people who had; there was also concern about how to handle dosing when switching people from a single drug regimen to the combination drug. In August 2016 the FDA told Sanofi that it was delaying a final decision for three months, and asked Sanofi for more data on how people used the delivery devices.Patent protection for lixisenatide expires in 2020. References
External links
"Lixisenatide". Drug Information Portal. U.S. National Library of Medicine.
Efavirenz/lamivudine/tenofovir (EFV/3TC/TDF), sold under the brand name Symfi among others, is a fixed-dose combination antiretroviral medication for the treatment of HIV/AIDS. It combines efavirenz, lamivudine, and tenofovir disoproxil. As of 2019, it is listed by the World Health Organization as an alternative first line option to dolutegravir/lamivudine/tenofovir. It is taken by mouth.Side effects can include joint pain, sleepiness, headaches, depression, trouble sleeping, and itchiness. Severe side effects may include depression, psychosis, or osteonecrosis. In those with a history of epilepsy, it may increase the frequency of seizures. Greater care should also be taken in those with kidney problems. Its use during pregnancy appears to be unsafe.It is on the World Health Organizations List of Essential Medicines. The combination received tentative approval in the United States in 2014, and was granted approval in February 2018. Its availability and importance is supported by Medecins Sans Frontieres. It is available as a generic medication. References
External links
"Efavirenz". Drug Information Portal. U.S. National Library of Medicine. "Lamivudine". Drug Information Portal. U.S. National Library of Medicine. "Tenofovir disoproxil". Drug Information Portal. U.S. National Library of Medicine. "Tenofovir disoproxil fumarate". Drug Information Portal. U.S. National Library of Medicine.