Rx Product News

JULY 15, 2009


Marketed by:
Spear Dermatology Products Inc (Randolph, NJ)Refissa
The FDA approved Refissa, a new formulation of
tretinoin, for the treatment of fine lines and wrinkles
on the face. It is the only 0.05% prescription-strength,
fragrance-free, emollient-based tretinoin cream on the
market. Refissa helps to reduce fine facial wrinkles,
rough skin, and irregular pigmentation. Its formulation
is for patients with normal-to-dry skin. Patients using
Refissa should also protect their skin from the sun by
wearing sunscreen.
Dosage Form:
40-g tube
For More Information:

Marketed by:
UCB (Brussels, Belgium)

UCB announced the FDA approval of Cimzia
(certolizumab pegol) for the treatment of adultCimzia
patients with moderately to severely active
rheumatoid arthritis (RA). The only PEGylated anti—tumor
necrosis factor, Cimzia can be dosed at 400 mg initially
and at weeks 2 and 4, followed by 200 mg every other week;
for maintenance dosing, 400 mg every 4 weeks can be considered.
Cimzia is administered by subcutaneous injection and
is also indicated for reducing the signs and symptoms
of Crohn’s disease and maintaining clinical response
in adult patients with moderately to severely active RA
who have had an inadequate response to conventional
Dosage Form:
200 mg lyophilized powder for reconstitution with
1 mL of sterile water for injection, USP; 200 mg/mL in a
single-use prefilled glass syringe
For More Information:

Marketed by:
Eli Lilly and Co (Indianapolis, IN)Symbyax
The FDA approved a new indication for
Symbyax (olanzapine and fluoxetine HCl
capsules). The approval makes Symbyax
the first-ever medication for treatmentresistant
depression, a condition in
which patients with major depressive
disorder do not respond adequately to
antidepressant therapy. The format of
the product labels was updated according
to the Physician’s Labeling Rule to include additional
information regarding weight gain, hyperglycemia, and
hyperlipidemia. Symbyax should not be used with a
monoamine oxidase inhibitor (MAOI) or within 14 days
of discontinuing an MAOI. At least 5 weeks should be
allowed after stopping Symbyax before starting an MAOI.
Thioridazine should not be given with Symbyax or within
5 weeks after stopping Symbyax. Concomitant use of
Symbyax with pimozide is contraindicated.
Dosage Form:
Capsules: 3/25 mg, 6/25 mg, 6/50 mg, 12/25 mg, and
12/50 mg (mg equivalent olanzapine/mg equivalent
For More Information:

Exforge HCT
Marketed by:Exforge HCT
Novartis (Basel, Switzerland)
Exforge HCT (amlodipine, valsartan,
hydrochlorothiazide) received FDA
approval for the treatment of hypertension
in patients not adequately controlled
on monotherapy and as initial therapy
in patients likely to need multiple drugs to reach their
blood pressure objectives. It is the only blood pressure
treatment that combines 3 medications in a single pill.
Exforge HCT combines a calcium channel blocker, angiotensin
receptor blocker, and diuretic, providing a new
option for patients who have tried taking dual combinations
of these classes of blood pressure medications
without success.
Dosage Form:
Tablets (amlodipine/valsartan/hydrochlorothiazide):
5/160/12.5 mg; 10/160/12.5 mg; 5/160/25 mg; 10/160/25
mg; and 10/320/25 mg
For More Information:


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