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You are currently browsing the Drug Kennel weblog archives for the day Monday, November 2nd, 2009.
Longer entries are truncated. Click the headline of an entry to read it in its entirety.
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- FDA Removes Unapproved Nitroglycerin Tablets
- FDA’s Determination of Vyvanse as NME Upheld
- FDA’s DAARP is now DAAP, DPAP is now DPARP
- Exalgo Approved
- Do Not Neglect Your Third-Party Drug Substance Manufacturer
- Proposed FDA rule would make Sponsors more responsible for data integrity - way more responsible
- Spending on DTC Ads
- Generic Approvals Taking Longer
- Can and Should ANDA Labeling Differ from the RLD?
- Roche’s Actemra Approved For RA After Year’s Delay
FDA warns P&G over use of Drug + Vitamin C
Published November 2nd, 2009 in 505(b)(2) Process and News Commentary. 0 CommentsLast Thursday, 10/29/2009, FDA sent P&G a warning letter regarding Vicks DayQuil Plus Vitamin C and Vicks NyQuil Plus Vitamin C. The FDA takes the position that these two products are unapproved drugs because they combine a (OTC) drug and a dietary supplement. The relevant passage from the FDA warning letter is:
Notwithstanding your attempt to market each [...]