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The FDA is requiring Concordia Pharmaceuticals to conduct drug interaction studies with its potassium-lowering drug Kayexalate, after the agency’s review of just-approved Veltassa showed that drug bound to about half of the oral medications tested. Read More
The FDA should establish searchable names and correct incomplete entries in its inactive ingredient database to enhance its accuracy and usability, generic drug and excipients makers say. Read More
Led by complaints about plaque psoriasis drugs, the FDA Adverse Event Reporting System recorded 205,389 primary suspect adverse event reports for 2,038 drugs in the second quarter of 2015, according to a new report by Advera Health Analytics. Read More
The FDA Wednesday approved Relypsa’s hyperkalemia therapy Veltassa — the company’s first product and the first advance in treating the life-threatening condition in more than five decades. Read More
FDA reviewers are questioning the safety and dosing of AztraZeneca’s investigational gout treatment lesinurad and whether a risk evaluation and mitigation strategy would suffice to address those concerns. Read More
A Texas drug compounder is recalling all lots of its sterile drug products after an FDA inspection found it had not investigated failed sterility tests. Read More
Drugmakers want the FDA to provide more details and examples of how it would show regulatory flexibility to developers of drugs for rare diseases, saying recent draft guidance is unclear about what may or may not be appropriate. Read More
The FDA hopes to cut down on patient-to-patient transmission of blood-borne infections by clearly labeling injectable therapies that are meant to be used multiple times by a single patient as products for “single-patient-use.” Read More