the treatment of post-menopausal osteoporosis in women at increased risk of fracture. Viviant was also approved in Japan in July 2010 for the treatment of post-menopausal osteoporosis.

In July 2007, Wyeth received an “approvable” letter from the FDA with respect to its NDA for the use of Pristiq in the treatment of moderate-to-severe vasomotor symptoms (VMS) associated with menopause. The FDA requested an additional one-year study of the safety of Pristiq for this indication. This study was recently completed, and the results were provided to the FDA in December 2010.

In December 2005, we received an “approvable” letter from the FDA for our Vfend pediatric filing that set forth the additional requirements for approval. In April 2010, based on data from a new pharmacokinetics study, we and the FDA agreed on a Vfend dosing regimen for pediatric patients in three ongoing trials. We continue to work with the FDA to determine the next steps.

The Lyrica NDA for monotherapy treatment of GAD was withdrawn in December 2010.

In December 2010, in the interest of patient safety, we voluntarily withdrew Thelin for the treatment of PAH in markets where it is approved. In addition, we discontinued clinical studies of Thelin worldwide for the treatment of PAH.

The NDAs for Fablyn (lasofoxifene) for the prevention and treatment of osteoporosis in post-menopausal women and for the treatment of vulvar and vaginal atrophy have been withdrawn. We are exploring strategic options for Fablyn, including but not limited to out-licensing or sale.

  Regulatory approvals and filings in the EU and Japan:

  DATE DATE PRODUCT DESCRIPTION OF EVENT APPROVED SUBMITTED

    Sutent Approval in the EU for treatment of pancreatic neuroendocrine tumor December 2010

    Prevenar 13 Application submitted in the EU for prevention of pneumococcal disease in December 2010 Adult adults 50 years of age and older

    Taliglucerase Application submitted in the EU for treatment of Gaucher disease November 2010 alfa

    Lyrica Approval in Japan for neuropathic pain October 2010 —

    Xalatan Approval in the EU for pediatric glaucoma September 2010

    Torisel Approval in Japan for renal cell carcinoma July 2010 —

    Genotropin Approval in the EU for adult growth hormone deficiency (Mark VII July 2010 — multidose disposable device)

    Viviant Approval in Japan for the treatment of post-menopausal osteoporosis July 2010 —

    atorvastatin Approval in the EU for type II variation for atorvastatin calcium July 2010 — calcium (SORTIS and associated names) for pediatric hyperlipidemia/

dyslipidemia

    tafamidis Application submitted in the EU for ATTR-PN — July 2010 meglumine

    Macugen Application submitted in the EU for type II variation for treatment of diabetic — June 2010 macular edema

    Genotropin Approval in Japan for adult growth hormone deficiency (Mark VII multidose June 2010 — disposable device)

    Lyrica Approval in Japan for the treatment of pain associated with post-herpetic

neuralgia April 2010 —

    Revatio Application submitted in the EU for pediatric PAH — February 2010

    Apixaban Application submitted in the EU for prevention of venous