Pfizer 2005 Annual Report Download - page 20

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2005 Financial Report 19
Financial Review
Pfizer Inc and Subsidiary Companies
Other Regulatory Approvals and Filings:
PRODUCT DESCRIPTION OF EVENT DATE APPROVED DATE SUBMITTED
Exubera Approved in the E.U. as an inhaled form of insulin for use in January 2006 —
adults with type 1 and type 2 diabetes
Macugen Approved in the E.U. for AMD January 2006 —
Approval in Canada and Brazil for AMD May 2005 —
Application submitted in Switzerland for AMD — January 2005
Application submitted in Australia for AMD — September 2004
Zoloft Approval in Japan for treatment of depression January 2006 —
Detrol/Detrol LA Approval in Japan for treatment of overactive bladder January 2006 —
Revatio Approval in the E.U. for treating PAH November 2005 —
Application submitted in Canada for treating PAH — December 2004
Caduet Approval in Canada for cardiovascular event prevention November 2005 —
Approval in certain E.U. countries for cardiovascular event July 2005 —
prevention
Champix Application submitted in the E.U. for smoking cessation — November 2005
Sutent Application submitted in Canada for mRCC and GIST — November 2005
Application submitted in the E.U. for mRCC and GIST — August 2005
Geodon/Zeldox Approval in the E.U. for treating manic or mixed episodes of October 2005 —
moderate severity in bipolar disorder
Somavert Approval in Canada for Acromegaly October 2005 —
Application submitted in Japan for Acromegaly — May 2005
Aromasin Approval in the E.U. for treating early breast cancer in August 2005 —
post-menopausal women
Aricept Approval in Canada for fast dissolving tablet July 2005 —
Lyrica Approval in Canada for neuropathic pain June 2005 —
Application submitted in the E.U. for treatment of generalized — June 2005
anxiety disorder (GAD) in adults
Fragmin Approval in the E.U. for treatment of deep vein thrombosis in April 2005 —
cancer patients
Vfend Approval in Japan for treatment of aspergillosis April 2005 —
Approval was granted in the E.U. for treatment of serious, January 2005 —
invasive, fluconazole-resistant candida infections and first-line
treatment of candidemia in non-neutropenic patients.
Zmax Application submitted in the E.U. for sustained release — October 2004
Genotropin Application submitted in Japan for treatment of short stature — July 2004
and growth problems
Neurontin Application submitted in Japan for epilepsy — April 2004
In January 2006, the CHMP, the scientific committee of the EMEA, finalized its scientific assessment and issued a positive opinion
recommending that marketing authorization be granted by the European Commission for Lyrica for the treatment of GAD in adults.
The approval requires final authorization from the European Commission.
Ongoing or planned clinical trials for additional uses and dosage forms for our products include:
PRODUCT INDICATION
Celebrex Sporadic adenomatous polyposis—a precancerous condition caused by growths (polyps) in the intestines
Camptosar IV Adjuvant colorectal cancer
Gastric cancer
Geodon/Zeldox Bipolar relapse prevention
Macugen Diabetic macular edema
Xalatan (new
delivery device) Ocular hypertension
Zyvox Catheter-related infections
Bone and joint infections