Store-brand phenylephrine products from Leiner will begin shipping in June to fill the gap on retail shelves left by pseudoephedrine, the private labeler announced April 22. The announcement follows Target's decision to place pseudoephedrine behind pharmacy counters. Phenylephrine is an active ingredient in Bayer's Alka-Seltzer Plus and compared to pseudoephedrine, "has fewer side effects and...does not interfere with sleep," Leiner claims. The firm's products will compete with Pfizer's Sudafed PE phenylephrine, launched in January, and other private-label offerings...
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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.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.
The reductions across medical product programs in the agency’s budget request include hundreds of positions funded by user fees, which may foreshadow its upcoming user fee restructuring strategy.
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
