OTC label redesign costs put at $5,072/SKU by NDMA, 145% higher than FDA projections.
This article was originally published in The Tan Sheet
Executive Summary
OTC LABELING REG: 19% OF OTCs WOULD GO OFF MARKET, NDMA PREDICTS, because they "don't fit" with FDA's proposed labeling requirements for OTC drugs, the association asserts in a Nov. 4 addendum to its comments on the proposed rule. "The majority of [stock-keeping units] that don't fit [with the reg] will be handled administratively," the Nonprescription Drug Manufacturers Association explains. "Nearly 11,000 SKUs will be withdrawn from the market during the two-year implementation period, and an additional 4,000 will be withdrawn as tentative final monographs are finalized," NDMA projects. "Nineteen percent of currently marketed OTC drug SKUs will be taken off the market."
You may also be interested in...
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
In Brief
Combe sells most of its OTC brands
People In Brief
Perrigo promotes in pricing, planning