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Tygacil Approval History

FDA Approved: Yes (First approved June 15, 2005)
Brand name: Tygacil
Generic name: tigecycline
Dosage form: Injection
Company: Wyeth Pharmaceuticals
Treatment for: Skin and Structure Infection, Intraabdominal Infection, Pneumonia

Tygacil (tigecycline) is a glycylcycline antibacterial indicated for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections and community-acquired bacterial pneumonia in adults.

Development History and FDA Approval Process for Tygacil

DateArticle
Mar 24, 2009Approval FDA Approves New Indication for Wyeth's Tygacil (tigecycline) for the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia
May 29, 2008Wyeth Receives Approvable Letter from FDA for Tygacil for theTreatment of Patients with Community-Acquired Pneumonia
Oct 24, 2007FDA Accepts Wyeth's Supplemental New Drug Application for Tygacil for the Treatment of Patients with Community-Acquired Pneumonia
Jul  6, 2007Wyeth to File for FDA Approval of Tygacil for the Treatment of Patients with Community-Acquired Pneumonia
Jun 15, 2005Approval Tygacil Wyeth Pharmaceuticals - Treatment for Complicated Skin and Intra-abdominal Infections
Jan 28, 2005FDA Grants Tygacil (Tigecycline) NDA Priority Review Status
Dec 15, 2004Wyeth Seeks Global Regulatory Approval of Tygacil (Tigecycline) for Injection

Further information

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