Claritin and hypospadia
This article was originally published in The Tan Sheet
FDA review of possible link between loratadine and birth defects "unlikely" to impact its decision on Schering-Plough's NDAs to switch Claritin OTC, agency says, noting many non-Rx products carry labeling restrictions concerning use during pregnancy. In addition to internal review being conducted by Division of Pulmonary & Allergy Drug Products and Office of Drug Safety, agency is consulting with outside experts in review of Swedish data, other information. FDA analysis, which extends to data for Rx Clarinex (desloratadine), could be completed by late September. Separate review by European Agency for the Evaluation of Medicinal Products is ongoing (1"The Tan Sheet" May 6, 2002, p. 3)...
You may also be interested in...
FDA's review of safety and birth registry data to determine whether Schering-Plough's Claritin (loratadine) could be linked to hypospadia is expected to take approximately three months
Public Company Edition: Mergers with special purpose acquisition corporations may be heating up, but in addition to the Surrozen and Tango SPAC deals Recursion and Biomea launched initial public offerings. Also, Organon sells $5.6bn worth of notes to fund spinout from Merck & Co.
Efforts to improve trial diversity predate COVID-19, but the pandemic’s disproportionate effects on minority communities have brought the issue to the forefront.