Remove 2007 Remove Licensing Remove Pharmacokinetics
article thumbnail

Gepirone

New Drug Approvals

5] History Gepirone was developed by Bristol-Myers Squibb in 1986, [5] but was out-licensed to Fabre-Kramer in 1993. 5] It was submitted for the preregistration (NDA) phase again in May 2007 after adding additional information from clinical trials as the FDA required in 2009. 1] It is taken orally. [1] 5] SYN Synthesis Ormaza, V.

FDA 62
article thumbnail

Landiolol

New Drug Approvals

Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics. The resulting Landiolol hydrochloride 2 has very high enantiomeric purity. 32 (2): 828. doi : 10.1016/j.joa.2015.09.002. 2015.09.002. PMC 4823575. PMID 27092187.

FDA 62
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

VALILTRAMIPROSATE

New Drug Approvals

2007 ; Kocis et al., Alzheon licensed ALZ-801 from NeuroChem and is developing it for Alzheimer’s disease. Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for the Treatment of Alzheimer’s Disease. Clin Pharmacokinet. 2016 ; Abushakra et al., 2018; 32(9): 849–861. [2].

article thumbnail

Trospium chloride

New Drug Approvals

6] It was first approved in the US in 2004, and an extended release version was brought to market in 2007. 9] [10] [11] Pharmacokinetics After oral administration, less than 10% of the dose is absorbed. Madaus had exclusively licensed the right to use the Regurin trademark to Speciality European Pharma Ltd. billion in 2004. [23]

article thumbnail

Making a “Miracle” HIV Medicine

Codon

By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. Starting in 2007, a human trial in Ecuador and Peru found that this drug duo reduced HIV incidence by 44 percent among men who have sex with men; adherence issues likely prevented full protection. This has happened before with other drugs.