Novex Pharma labeling deferrals
This article was originally published in The Tan Sheet
Canadian private labeler's deferral requests from OTC labeling final rule for Minoxidil Topical Solution 2% (Pharmacia's Rogaine Regular Strength for Men, Rogaine for Women) and Minoxidil Topical Solution 5% For Men (Rogaine Extra Strength for Men) are "appropriate," considering "the time that it has taken to finalize current FDA Drug Facts template labeling," agency says in Feb. 4 correspondence. Letter responds to Novex' Nov. 15 citizen petition. FDA has indicated it will revise the template for the 2% product; no template exists for the 5% version (1"The Tan Sheet" Dec. 10, 2001, p. 3)...
You may also be interested in...
McNeil Consumer Healthcare is requesting a six-month deferral from the OTC labeling final rule requirements to implement "booklet pouch" labeling for two-count sizes of five products
South Korean pharma HK inno.N’s $500m IPO has drawn strong interest with subscriptions from institutional investors marking a record high. The IPO should help it speed up development of cell and gene therapies and beef up its vaccines business.
An interactive look at recent executive-level company changes and promotions in the biopharma, medical device and diagnostics industries.