Laxatives monograph clarification
This article was originally published in The Tan Sheet
Executive Summary
CHPA asks FDA to accept the statement of identity "fiber laxative" as well as "the indication 'Fiber therapy for relief of occasional constipation' [which may be followed by '(irregularity)']" in a Jan. 20 letter. The trade group also requests clarification on whether "'fiber laxative' may be used as an alternative to 'bulk-forming laxative.'" CHPA's request comes after the October 2003 reopening of the administrative record for OTC laxatives (1"The Tan Sheet" Oct. 27, 2003, In Brief)...
You may also be interested in...
Laxative record open
FDA is reopening the administrative record for OTC laxative products until Jan. 20, 2004, agency announces in Oct. 22 1Federal Register. Agency explains it "has received new data and information submitted to the rulemaking for OTC laxative drug products after the administrative record closed on the various dates" since the 1985 tentative final monograph. Separately, comments on the agency's proposal to reclassify granular psyllium as Category II (not generally recognized as safe and effective) from Category I (generally recognized as safe and effective) are due Nov. 3, FDA says (2"The Tan Sheet" Aug. 11, 2003, p. 10)...
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.