ACAM2000
 |
Marketed by:
Acambis plc
(Cambridge, UK,
and Cambridge, Mass)
Indication:
August 31, 2007—The FDA approved Acambis plc's
ACAM2000 (Smallpox [Vaccinia] Vaccine, Live) vaccine
for active immunization against smallpox disease for
persons determined to be at high risk for smallpox
infection. ACAM2000 is supplied as a single-dose vaccine
administered percutaneously. It is made using a
pox virus called vaccinia, which is related to but different
from the virus that causes smallpox. The vaccine
contains live vaccinia virus and works by causing a
mild infection that stimulates an immune response
that effectively protects against smallpox without
actually causing the disease. Acambis developed
ACAM2000 under contracts with the US Centers for
Disease Control and Prevention (CDC) as part of its
preparations for a public health emergency.
Dosage Form:
Lyophilized powder reconstituted with packaged diluent.
After reconstitution, each vial has approximately
100 doses of 0.0025 mL of live vaccinia virus containing
2.5-12.5 x 105 plaque-forming units.
For More Information:
866-440-9440
www.acambis.com
Evista
 |
Marketed by:
Eli Lilly and Co
(Indianapolis, Ind)
Indication:
September 14, 2007—Eli Lilly and Co announced that
the FDA approved Evista (raloxifene HCl), its osteoporosis
drug, for a new use to reduce the risk of invasive
breast cancer in 2 populations: postmenopausal
women with osteoporosis and postmenopausal
women at high risk for invasive breast cancer. Evista,
a selective estrogen receptor modulator (recently
classified by the FDA as an estrogen agonist/antagonist),
is already approved for the prevention and treatment
of osteoporosis in postmenopausal women.
Evista represents 1 treatment option that can help
address 2 leading health concerns—osteoporosis and
invasive breast cancer. The American Cancer Society
estimates that approximately 180,000 women are
diagnosed with invasive breast cancer each year.
Dosage Form:
Tablets: 60 mg
For More Information:
www.evista.com
Norditropin
 |
Marketed by:
Novo Nordisk
(Princeton, NJ)
Indication:
September 21, 2007—
Novo Nordisk
announced that the FDA approved Norditropin (somatropin
[rDNA origin] injection) for the treatment of children
with short stature associated with Turner syndrome.
Turner syndrome is a rare chromosomal condition
caused by complete or partial absence of the
second sex chromosome (X chromosome) in females.
This occurs in approximately 1 in 2500 live female
births and in as many as 10% of all miscarriages
worldwide. A majority of patients (90%-100% depending
on the chromosomal abnormalities) with Turner
syndrome have a short stature. Norditropin also is
indicated for the treatment of children with short
stature associated with Noonan syndrome, for treatment
of children with growth failure due to growth
hormone deficiency (GHD), and for treatment of adults
with either adult- or childhood-onset GHD.
Dosage Form:
5 mg/1.5 mL: cartridge and Norditropin NordiFlex pen;
10 mg/1.5 mL: Norditropin NordiFlex pen only; 15
mg/1.5 mL: cartridge and Norditropin NordiFlex pen
For More Information:
888-NOVO-444 (888-668-6444)
www.norditropin-us.com
Opana ER
 |
Marketed by:
Endo Pharmaceuticals Inc
(Chadds Ford, Pa)
Indication:
October 1, 2007—Endo
Pharmaceuticals Inc
announced a new appearance
for Opana ER (oxymorphone
HCl) extendedrelease
tablets CII. Opana ER tablets will be changed
from an imprinted-tablet appearance to a debossedtablet
appearance. Imprinted Opana ER tablets have
product markings that are printed in black ink on the
surface of each tablet. The new appearance for Opana
ER will now have product markings that are pressed
into the surface of each 5-, 10-, 20-, and 40-mg tablet.
Opana ER is indicated for the relief of moderate-tosevere
pain in patients requiring continuous, aroundthe-
clock opioid treatment for an extended period of
time.
Dosage Form:
Tablets: 5, 10, 20, and 40 mg
For More Information:
800-462-ENDO (800-462-3636)
www.opana.com
Ranexa
 |
Marketed by:
CV Therapeutics
(Palo Alto, Calif)
Indication:
August 14, 2007—CV Therapeutics
announced the FDA approval and
launch of the 1000-mg tablet formulation
of Ranexa (ranolazine extended-
release tablets). The approved
product labeling recommends that
Ranexa be initiated at 500 mg bid and
increased to 1000 mg bid, as needed, based on clinical
symptoms. Previously, patients who were taking
1000 mg bid had to take four 500-mg tablets per day.
These patients now have the option of taking two
1000-mg tablets per day. Ranexa is indicated for the
treatment of chronic angina in patients who have not
achieved an adequate response with other antianginal
drugs, and should be used in combination with
amlodipine, beta-blockers, or nitrates.
Dosage Form:
Tablets: 500 and 1000 mg
For More Information:
www.ranexa.com
www.cvt.com
Stalevo
 |
Marketed by:
Novartis Pharmaceuticals Corp
(East Hanover, NJ)
Indication:
August 6, 2007—The FDA
approved a new, higher-dose
strength of Stalevo (carbidopa,
levodopa,and entacapone),
according to Novartis
Pharmaceuticals Corp. Stalevo
is indicated for Parkinson's disease patients with signs
and symptoms of end-of-dose "wearing off." Stalevo is
now available in a 200-mg dose (50 mg carbidopa,
200 mg levodopa, and 200 mg entacapone), which
provides greater dosing flexibility in the treatment of
Parkinson's disease patients and may lessen the burden
of managing multiple medications among
patients and their caregivers. Stalevo is approved to
substitute immediate-release carbidopa/levodopa and
entacapone previously administered as individual
products, or to replace immediate-release
carbidopa/levodopa therapy, without entacapone, in
certain Parkinson's disease patients who are experiencing
the signs and symptoms of end-of-dose wearing
off.
Dosage Form:
Tablets: 50, 100, 150, and 200 mg
For More Information:
www.stalevo.com
Tersi Foam
 |
Marketed by:
Quinnova Pharmaceuticals Inc
(Newtown, Pa)
Indication:
August 1, 2007?Quinnova
Pharmaceuticals announced
the introduction of Tersi Foam
(selenium sulfide in a waterand
lipid-based foam, 2.25%), which is indicated for
the treatment of seborrheic dermatitis and tinea versicolor.
Tersi Foam, an antiseborrheic, antifungal preparation,
is applied topically for the treatment of seborrheic
dermatitis and tinea versicolor of the skin, combining
Proderm Technology with the effectiveness of
selenium sulfide 2.25%. Proderm Technology is a
water?lipid-based foam that mimics the water?lipidbased
structure of the skin.
Dosage Form:
70-g aerosolized canister
For More Information:
866-210-1129
www.quinnova.com