FDA's NDA And BLA Approvals: Vermox, Zinplava
Executive Summary
Below are FDA's original approvals of NDAs and BLAs issued in the past week. Please see key below chart for a guide to frequently used abbreviations.
Below are FDA's original approvals of NDAs and BLAs issued in the past week. Please see key below chart for a guide to frequently used abbreviations.
|
Sponsor |
Product |
Indication |
Code |
Approval Date |
|
New Drugs |
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|
Janssen |
Vermox (mebendazole) |
Chewable formulation of mebendazole for the treatment of patients one year of age and older with gastrointestinal infections caused by Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm) (Also see "Keeping Track: Oncology Approvals And Responses To Complete Response Letters" - Pink Sheet, 22 Oct, 2016.) |
5 |
10/19/2016 |
|
New Biologics |
||||
|
Merck |
Zinplava (bezlotoxumab) |
To reduce recurrence of Clostridium difficile infection in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at a high risk for CDI recurrence (Also see "Merck’s C. Diff Drug Zinplava Clears FDA With Heart Failure Warning" - Pink Sheet, 25 Oct, 2016.) |
|
10/21/2016 |
|
Key To Abbreviations |
|
Review Classification |
|
P: Priority review; S: Standard review; O: Orphan Drug |
|
NDA Chemical Types |
|
1: New molecular entity (NME); 2: New active ingredient; 3: New dosage form; 4: New Combination 5: New formulation or new manufacturer; 6: New indication; 7: Drug already marketed without an approved NDA; 8: OTC (over-the-counter) switch; 9: New indication submitted as distinct NDA – consolidated with original NDA; 10: New indication submitted as distinct NDA - not consolidated with original NDA |