Pfizer 2007 Annual Report Download - page 23

We received an “approvable” letter from the FDA for fesoterodine
for the treatment of overactive bladder in January 2007.
Regulatory review of fesoterodine is progressing in the U.S. and
fesoterodine was approved in the E.U. in April 2007. We are
working with Schwarz Pharma, the licensor, to scale up
manufacturing and identify manufacturing site alternatives.
Launch is planned for mid-2008 in Europe and, subject to FDA
approval, early 2009 in the U.S.
In December 2007, we received a third “approvable” letter from
the FDA for dalbavancin. We and the third-party manufacturer
are working with the FDA to respond to the requirements set forth
in that letter.
We received “not-approvable” letters from the FDA for Fablyn
(lasofoxifene) for the prevention of post-menopausal osteoporosis
in September 2005 and for the treatment of vaginal atrophy in
January 2006. We submitted a new NDA for the treatment of
osteoporosis in post-menopausal women in December 2007,
including the three-year interim data from the Postmenopausal
Evaluation And Risk-reduction with Lasofoxifene (PEARL) study
in support of the new NDA.
In September 2005, we received a “not-approvable” letter for
Dynastat (parecoxib), an injectable prodrug for valdecoxib for the
treatment of acute pain. We have had discussions with the FDA
regarding this letter, and we are considering plans to address the
FDA’s concerns.
Regulatory approvals and filings in the E.U. and Japan:
PRODUCT DESCRIPTION OF EVENT DATE APPROVED DATE SUBMITTED
Fablyn/ Application submitted — January 2008
(lasofoxifene) in the E.U. for the
treatment of
osteoporosis
Chantix/ Approval in Japan as January 2008 —
Champix an aid to smoking
cessation
Spiriva Approval in the E.U. November 2007 —
for Respimat device
for chronic
obstructive
pulmonary disease
Caduet Application submitted — November 2007
in Japan for
hypertension
Celsentri Approval in the E.U. September 2007 —
(maraviroc) for the treatment
of HIV in CCR5-
tropic treatment-
experienced patients
Eraxis/Ecalta Approval in the E.U. September 2007 —
for the treatment
of invasive candidiasis
in adult non-
neutropenic patients
Selera Approval in Japan for September 2007 —
(Inspra) treatment of
hypertension
dalbavancin Application submitted — July 2007
in the E.U. for the
treatment of skin
and skin structure
infections
Regulatory approvals and filings in the E.U. and Japan:
(continued)
PRODUCT DESCRIPTION OF EVENT DATE APPROVED DATE SUBMITTED
rifabutin Application submitted — June 2007
in Japan for
Mycobacterium
infection
fesoterodine Approval in the E.U. April 2007 —
for treatment of
overactive bladder
Macugen Application submitted — March 2007
in Japan for
treatment of age-
related macular
degeneration
Celebrex Approval in the E.U. February 2007 —
for the treatment
of ankylosing
spondylitis
Application submitted — February 2007
in Japan for
treatment of lower-
back pain
Approval in Japan January 2007 —
for treatment of
osteoarthritis and
rheumatoid arthritis
sildenafil Application submitted — February 2007
in Japan for
treatment of
pulmonary arterial
hypertension
Somavert Approval in Japan January 2007 —
for treatment of
acromegaly
Sutent Approval in the E.U. January 2007 —
for mRCC as a
first-line treatment
Approval in the E.U. January 2007 —
for GIST as a
second-line
treatment
Application submitted — December 2006
in Japan for
treatment of mRCC
Application submitted — December 2006
in Japan for
treatment of GIST
Ongoing or planned clinical trials for additional uses
and dosage forms for our in-line products include:
PRODUCT INDICATION
Celebrex Acute gouty arthritis
Eraxis/Vfend Aspergillosis fungal infections
Combination
Geodon/ Bipolar relapse prevention; pediatric bipolar mania;
Zeldox adjunctive use in bipolar depression
Lyrica Epilepsy monotherapy
Macugen Diabetic macular edema
Revatio Pediatric pulmonary arterial hypertension
Selzentry/ HIV in CCR5-tropic treatment-naive patients
Celsentri
Sutent Breast cancer; colorectal cancer; non-small cell
lung cancer; liver cancer
Zithromax/ Malaria
chloroquine
2007 Financial Report 21
Financial Review
Pfizer Inc and Subsidiary Companies