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You are currently browsing the Drug Kennel weblog archives for the day Monday, November 16th, 2009.
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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 approves Xanodyne’s tranexamic acid
Published November 16th, 2009 in Events and News Commentary. 0 CommentsXanodyne obtained 505(b)(2) approval for tranexamic acid for use in treating heavy menstrual bleeding (menorrhagia). The RLD is Cyklokapron(R) which is used to treat hemophilia and to reduce the need for replacement therapy during and following tooth extraction. The RLD received orphan approval in 1986. Initially, both tablet and injectable dosage forms were approved but [...]