Rx Product News

Pharmacy Times, July 2009, Volume 75, Issue 7

HOT RXRefissa

Marketed by:

Spear Dermatology Products Inc (Randolph, NJ)

Indication:

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:

www.refissa.com

Cimzia

Marketed by:

UCB (Brussels, Belgium)

Indication:

UCB announced the FDA approval of Cimzia

(certolizumab pegol) for the treatment of adult

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

therapy.

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:

www.cimzia.com

Symbyax

Marketed by:

Eli Lilly and Co (Indianapolis, IN)

Indication:

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

fluoxetine)

For More Information:

www.symbyax.com

Exforge HCT

Marketed by:

Novartis (Basel, Switzerland)

Indication:

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:

www.exforgehct.com