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Telavancin
Systematic (IUPAC) name
(1S,2R,18R,19R,22 S,25R,28R,40S)-22-(2-amino-2-oxoethyl)-5,15-dichloro-48-{[(2 S,3R,4S,5S,6R)-3-[((2S,4 S,5S,6S)-4-{[2-(decylamino)ethyl]amino}-5-hydroxy-4,6-dimethyltetrahydro-2 H-pyran-2-yl)oxy]-4,5-dihydroxy-6-(hydroxymethyl)tetrahydro-2 H-pyran-2-yl]oxy}-2,18,32,35,37-pentahydroxy-19-{[(2R)-4-methyl-2-(methylamino)pentanoyl]amino}-20,23,26,42,44-pentaoxo-36-{[(phosphonomethyl)amino]methyl}-7,13-dioxa-21,24,27,41,43-pentaazaoctacyclo[26.14.2.2 3,6.214,17.18,12.129,33.0 10,25.034,

39]pentaconta-3,5,8(48),9,11,14,16,29(45),30,32,34,36,38,46,49-pentadecaene-40-carboxylic acid

Identifiers
CAS number 372151-71-8
ATC code J01XA03
PubChem 3081362
Chemical data
Formula C 80H106Cl2N11O27P 
Mol. mass 1755.63
Pharmacokinetic data
Bioavailability N/A
Metabolism  ?
Half life 9 hours
Excretion  ?
Therapeutic considerations
Licence data

US FDA:link

Pregnancy cat. C(US)
Legal status -only (US)
Routes intravenous

Telavancin (trade name Vibativ) is a bactericidal lipoglycopeptide under trial for use in MRSA or other Gram-positive infections. Telavancin is a synthetic derivative of vancomycin.[1]

On October 19, 2007, the US Food and Drug Administration (FDA) issued an approvable letter for telavancin. Its developer, Theravance, Inc. submitted a complete response to the letter, and the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of July 21, 2008. [2]

Contents

History

On November 19, 2008, an FDA antiinfective drug advisory committee concluded that they would recommend Telavancin be approved by the FDA. Although the FDA is not bound to honor the recommendations made to it by its advisory committees, it does in most cases.

In late April 2009, the FDA accepted for review Theravance's response to the February 2009 Complete Response letter, which outlined requirements for approval of telavancin for the treatment of complicated skin and skin structure infections (cSSSI). The FDA approved the drug on September 11, 2009.[3]

Theravance has also submitted Telavancin to the FDA in a second indication, nosocomial pneumonia, sometimes referred to as hospital-acquired pneumonia, or HAP. The PDUFA goal date for this indication is November 26, 2009.

Mechanism of action

Like vancomycin, telavancin inhibits cell wall synthesis (see Pharmacology and chemistry of vancomycin). In addition, it disrupts bacterial membranes by depolarization.[4]

References

  1. ^ Astellas, Inc. VIBATIV prescribing information, 9/2009.
  2. ^ "Drugs.com, FDA Accepts for Review Response to Approvable Letter for Telavancin". http://www.drugs.com/nda/telavancin_080306.html. Retrieved 2008-03-08.  
  3. ^ Theravance, Inc. and Astellas Pharma US, Inc. (2009-09-11). "Theravance and Astellas Announce FDA Approval of Vibativ (telavancin) for the Treatment of Complicated Skin and Skin Structure Infections". Press release. http://www.drugs.com/newdrugs/theravance-astellas-announce-fda-approval-vibativ-telavancin-complicated-skin-skin-structure-1629.html. Retrieved September 16, 2009.  
  4. ^ H. Spreitzer (2 February 2009). "Neue Wirkstoffe - Telavancin" (in German). Österreichische Apothekerzeitung (3/2009).  

External links








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