FDA Approval Generic Drugs Regulation Trials 
XTalks
FEBRUARY 5, 2024
Read on to learn more about the top 40 best-selling oncology drugs in 2023, based on 2022 sales data. Nevertheless, Opdivo continues to hold strong and Bristol Myers Squibb filed an application with the FDA in December for Opdivo in combination with cisplatin chemotherapy as a first-line treatment in advanced urothelial carcinoma.
Camargo
NOVEMBER 11, 2020
In October, Antares Pharma licensed Ferring Pharmaceuticals’ Nocdurna® (desmopressin acetate) sublingual tablet , which was approved in 2018 for the same indication as Noctiva and has a boxed warning highlighting the same risks. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product.
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XTalks
FEBRUARY 5, 2024
Read on to learn more about the top 40 best-selling oncology drugs in 2023, based on 2022 sales data. Nevertheless, Opdivo continues to hold strong and Bristol Myers Squibb filed an application with the FDA in December for Opdivo in combination with cisplatin chemotherapy as a first-line treatment in advanced urothelial carcinoma.
Pharmaceutical Technology
NOVEMBER 29, 2022
The company now plans to move this approach into a Phase III trial. In 1970, the FDA approved ketamine as an anesthetic. The drug is also known for its illegal recreational use. Since ketamine is a generic drug, it is not lucrative to study for pharmaceutical companies, he adds.
pharmaphorum
AUGUST 28, 2020
An androgen receptor inhibitor, Winlevi (clascoterone) has been cleared by the US regulator for the treatment of acne in patients 12 years and older and is due to be launched early next year, according to the company. Retinoids can help unclog pores, while antibiotics can limit the growth of bacteria.
The Pharma Data
MAY 17, 2021
The authority to change drug labels outside of considerations for new safety information “could encourage third parties, such as academic investigators, insurance companies, and cooperative trial groups, to initiate such changes,” they wrote. .
The Pharma Data
MAY 7, 2021
Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug ( Endpoints ). WHO approves emergency use of China’s Sinopharm Covid vaccine ( FT ). US move to loosen vaccine patents will draw drug companies to bargain ( Reuters ). Generic Drug Cos. .
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