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Tygacil FDA 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 timeline 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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