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The combination drug was approved for medical use in the United States in February 2017, where it also is sold under the brand name Qtern. [ 61 ] [ 62 ] In May 2019, the fixed-dose combination of dapagliflozin, saxagliptin, and metformin hydrochloride as extended-release tablets was approved in the United States to improve glycemic control in ...
Food and Drug Administration (FDA) approval date: European Medicines Agency (EMA) approval date: Health Canada approval date: Company: Single-tablet regimen? NRTIs / NtRTIs: NNRTI: INSTI: PI: PK enhancer: Combivir: lamivudine zidovudine: September 26, 1997 ViiV Healthcare: No Kaletra (developed countries) Aluvia (developing countries) lopinavir ...
Sotagliflozin (Inpefa) is a dual SGLT1/SGLT2 inhibitor approved by the US Food and Drug Administration (FDA) in May 2023, to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors.
The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications, [1] and while there is no official list of PDUFA dates, [10] several websites collect PDUFA dates from press announcements in a calendar form.
MS Contin is a DEA Schedule II substance in the United States, a Schedule 8 (controlled) drug in Australia and a Schedule 2 CD (Controlled Drug) in the UK. Avinza is made by King Pharmaceuticals and Kadian is made by Actavis Pharmaceuticals. Unlike the MS Contin brand and its generic versions, Kadian and Avinza are designed to be 12- to 24-hour ...
Pfizer's shot, Prevnar 20, was approved in 2021 for use in adults aged 18 years or older and protects against 20 serotypes. It is also approved for use in six-weeks old infants to 17-year olds.
Citing major developments and a market capitalization of US$87 billion and stock appreciation of 61.4%, Bristol-Myers Squibb was ranked as the best drug company of 2013 by Forbes magazine. [ 46 ] In December 2014, the company received FDA approval for the use of the PD-1 inhibitor nivolumab (Opdivo) in treating patients whose skin cancer cannot ...
The FDA gave notice of a possible rule in 2023 with an initial target date to release the proposal in April. That was then moved to July before jumping to September.