Amrix
Marketed by:
Cephalon Inc
(Frazer, PA)
Indication:
October 3, 2007—Cephalon
announced that, beginning in
October, Amrix (cyclobenzaprine
hydrochloride extended-
release capsules) would be available in pharmacies
in the United States. Originally approved by the FDA in
February 2007, Amrix is the first and only once-daily
formulation of the skeletal muscle relaxant cyclobenzaprine
hydrochloride. The medication is indicated as
an adjunct to rest and physical therapy for the relief of
muscle spasm associated with acute, painful musculoskeletal
conditions and is intended for short-term
use (up to 2 or 3 weeks). Cephalon acquired the North
American rights to Amrix from ECR Pharmaceuticals, a
privately held company, in August 2007. Amrix provides
once-daily dosing. It can be taken in the daytime
or at nighttime, but it should be taken at approximately
the same time every day.
Dosage Form:
Extended-release capsules: 15 and 30 mg
For More Information:
www.amrix.com
800-896-5855
Cymbalta
Marketed by:
Eli Lilly and Co
(Indianapolis, IN)
Indication:
November 30, 2007—Eli Lilly
and Co announced that the
FDA approved Cymbalta (duloxetine
HCl) for the maintenance
treatment of major depressive
disorder (MDD) in adults. Treating the broad range of
depression symptoms (eg, sadness, loss of interest,
and fatigue) may minimize the presence of residual
symptoms (eg, anxiety, guilt, and low self-esteem) and
can help delay the time to relapse. Cymbalta, which
belongs to a class of drugs commonly referred to as
serotonin and norepinephrine reuptake inhibitors
(SNRIs), is already approved for the acute treatment of
MDD, the management of diabetic peripheral neuropathic
pain, and the treatment of generalized anxiety
disorder, all in adults.
Dosage Form:
Capsules: 20, 30, and 60 mg
For More Information:
www.cymbalta.com
800-LILLY-RX (800-545-5979)
Hot Rx |
CaloMist
Marketed by:
Fleming Pharmaceuticals
(St Louis, MO)
Indication:
November 28, 2007—
Fleming Pharmaceuticals
today announced the
availability of CaloMist
(cyanocobalamin, USP), the
first and only FDA-approved,
once-daily vitamin B12 nasal spray. CaloMist was
developed as a maintenance alternative to ongoing
B12 intramuscular (IM) injections for patients whose
B12 levels have been normalized with IM injections.
Vitamin B12 deficiency is more common in the elderly
and in adults. Vitamin B12 deficiency is often undetected
and can lead to serious neuropsychiatric and
hematologic complications, including fatigue, weakness,
loss of memory, depression, and anemia.
Dosage Form:
Nasal spray: 25 mcg cyanocobalamin, USP/0.1 mL
For More Information:
www.flemingpharma.com
800-343-9497
|
Nexavar
Marketed by:
Bayer Pharmaceuticals
Corp (West Haven, CT) and
Onyx Pharmaceuticals Inc
(Emeryville, CA)
Indication:
November 19, 2007—Bayer
HealthCare AG and Onyx Pharmaceuticals Inc announced
that the FDA approved a supplemental new
drug application for Nexavar (sorafenib) tablets for the
treatment of patients with unresectable hepatocellular
carcinoma (HCC), or liver cancer. Nexavar, an oral anti-cancer
drug, is the first approved systemic drug therapy
for liver cancer and the only drug therapy shown to
significantly improve overall survival in patients with
the disease. Nexavar also is indicated for the treatment
of advanced renal cell carcinoma, or advanced
kidney cancer. When it received this approval in 2005,
Nexavar became the first new treatment in more than
a decade for advanced kidney cancer and is currently
approved in more than 60 countries for this indication.
Dosage Form:
Tablets: 200 mg
For More Information:
www.nexavar.com
866-NEXAVAR (866-639-2827)
