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Merck's Gardasil 9 Receives FDA's Expanded Label Approval for Prevention of HPV Related Disorders

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Merck's Gardasil 9 Receives FDA's Expanded Label Approval for Prevention of HPV Related Disorders

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  • The approval is based on a study assessing Gardasil 9 in 13-000 patients (age 27- 45 yrs) for the prevention of certain cancers and diseases caused by the nine HPV types- testing its safety and efficacy
  • In 2006 & 2014- FDA approved Gardasil (for females) & Gardasil 9 (males & females- aged 9 to 26 yrs.) to prevent certain cancers and diseases caused by four (6- 11- 16 & 18) HPV types and additional five (31- 33- 45- 52 & 58) HPV types respectively
  • Gardasil 9 is a vaccine indicated for the prevention of cervical- vulvar- vaginal- and anal cancers caused by HPV in women and prevention of anal cancer in men and also received FDA’s PR designation

Ref: Merck & Co. | Image: Merck


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