Nasalcrom new product bulletin: American Pharmaceutical Association booklet advises pharmacists that "cromolyn sodium in oral, parenteral and inhaled forms has a wide margin of safety" and "the risk of toxicity from an overdose is extremely low"; however, "patients should be warned that cromolyn sodium can cause transient nasal stinging, sneezing, or both immediately after administration of the drug." These effects "rarely require discontinuation of therapy." Cromolyn sodium is "well tolerated and has few precautions" and "may be useful for patients who cannot take or tolerate antihistamines and decongestants because of concomitant medical conditions or adverse effects" or in patients whose symptoms are not controlled by these types of medications. The allergy prevention and treatment product was recently purchased from Rx-to-OTC switch sponsor McNeil Consumer Products by Pharmacia & Upjohn ("The Tan Sheet" June 9, p. 2)...
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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.’
Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.
