CIBA-GEIGY's SECOND BETA-BLOCKER IS TRASICOR (OXPRENOLOL), which received FDA approval for the treatment of hypertension on Dec. 29. The product, developed by Ciba, joins Geigy's Lopressor (metoprolol) which has been marketed in the U.S. since 1978. Trasicor is Ciba-Geigy's first new chemical entity approval since the agency cleared the antidepressant Ludiomil in late 1980. Schering A.G.'s Berlex subsidiary has co-marketing rights to the drug in the U.S. under a licensing agreement. Berlex has given the drug the tradename ISET. Neither firm has announced marketing plans for the drug. FDA classified oxprenolol under its internal classification system as 1C, a new chemical entity that the agency believes represents "little or no therapeutic gain." The drug was reviewed by the agency's Cardio-Renal Advisory Cmte. in February 1980. At that time the cmte. recommended that prior to approval the target population be better defined in view of clinical trial results that found the drug less effective than propranolol. Oxprenolol was approved in three dosages, 20 mg, 40 mg, and 100 mg caps. The labeling calls for t.i.d. administration.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
ZIN, the Dutch health technology assessment body, estimates that the number of patients eligible for treatment with a PARP inhibitor will be halved following a reassessment of drugs in the class.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.
