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Shingrix Approval History

FDA Approved: Yes (First approved October 20, 2017)
Brand name: Shingrix
Generic name: zoster vaccine recombinant, adjuvanted
Dosage form: Injection
Company: GlaxoSmithKline
Treatment for: Herpes Zoster, Prophylaxis

Shingrix (zoster vaccine recombinant, adjuvanted) is a non-live, recombinant subunit vaccine for the prevention of herpes zoster (shingles) in adults aged 50 years and older.

Development History and FDA Approval Process for Shingrix

DateArticle
Oct 20, 2017Approval Shingrix (zoster vaccine recombinant, adjuvanted) Approved in the U.S. for Prevention of Shingles
Sep 13, 2017FDA Advisory Committee Votes Unanimously for Shingrix (HZ/su) in the US for Prevention of Herpes Zoster (Shingles) in Adults Ages 50 and Over
Jun 21, 2017GSK Presents Positive Results from Phase III Revaccination Study of its Candidate Shingles Vaccine Shingrix at CDC’s Advisory Meeting

Further information

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