Desvenlafaxine
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Desvenlafaxine
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Systematic (IUPAC) name | |
4-[2-dimethylamino-1-(1-hydroxycyclohexyl) ethyl]phenol |
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Identifiers | |
CAS number | |
ATC code | ? |
PubChem | |
Chemical data | |
Formula | C16H25NO2 |
Mol. mass | 263.375 g/mol |
Synonyms | O-desmethylvenlafaxine Norvenlafaxine |
Pharmacokinetic data | |
Bioavailability | ? |
Metabolism | ? |
Half life | ? |
Excretion | ? |
Therapeutic considerations | |
Pregnancy cat. |
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Legal status | |
Routes | ? |
Desvenlafaxine succinate, marketed under the name Pristiq, is an antidepressant of the serotonin-norepinephrine reuptake inhibitor class from Wyeth. It is a metabolite of venlafaxine (Effexor).
[edit] Approval status
It has completed Phase III trials and is waiting for approval by the U.S. Food and Drug Administration. Wyeth announced on January 23 that they received an "approvable" letter from the FDA for venlafaxine. Final approval to sell the drug is contingent on a number of things, including:
- a satisfactory FDA inspection of Wyeth's Guayama, Puerto Rico facility, where the drug is to be manufactured;
- several post-marketing commitments;
- clarity by Wyeth around the company's product education plan for physicians and patients;
- approval of desvenlafaxine's proprietary name, Pristiq.[1]
Wyeth expects the drug to be approved for sales in early 2007.[2]
[edit] References
- ^ (January 23, 2007). Wyeth Receives Approvable Letter From FDA For Pristiq (Desvenlafaxine Succinate) For The Treatment Of Major Depressive Disorder. Press release. Retrieved on 2007-04-04.
- ^ Wyeth (August 29, 2006). Re-formatted Data Submission Results in Extension of FDA Review for Desvenlafaxine Succinate. Press release. Retrieved on 2007-04-04.