Drug Class Generic/Trade
Company Names
Indication Approving
Regulatory
Agency
Actinic
Keratosis
Methyl Aminolevulinate HCl
Cream

Metvixia™ + Aktilite® CL128
Photocure ASA/ Galderma

Approved for the treatment of actinic keratosis.

US FDA
Antiacne Agents Adapalene 0.1%
Differin® Gel
Galderma KK/ Schionogi

Approved for the treatment of acne vulgaris.

Japan’s
Ministry
of Health,
Labour &
Welfare
Clindamycin Phosphate 1.2% +
Benzoyl Peroxide 2.5%

Acanya® Gel
Arcutis Pharmaceuticals

Approved for the once daily treatment of both noninflammatory
and inflammatory acne lesions in
patients 12 years of age and older.

US FDA
Antibacterial
Agent
Ceftobiprole Medocaril IV
ZEFTERA®
Basilea Pharmaceuticals

Approved for the treatment of complicated skin
and soft tissue infections, including diabetic foot
infections. In Switzerland, this includes nonlimb-
threatening diabetic food infections without
concomitant osteomyelitis.

Health
Canada,
Swissmedic
Anticancer
Agent
Denileukin Diftitox
Ontak®
Esai Corporation

Approved for the treatment of patients with persistent
or recurrent cutaneous T-cell lymphoma whose
malignant cells express the CD25 component of the
IL-2 receptor (CD25+).

US FDA
Antihistamine Loratadine
Claritin®
Schering-Plough

Approved labeling change to advise consumers that
this OTC formulation relieves allergy symptoms
caused by both perennial and seasonal allergies.

US FDA
Antipruritic
Agent
Levocetirizine Dihydrochloride
0.5mg/ml Oral Solution

Xyzal®
UCB & sanofi aventis

Approved for the relief of symptoms associated
with indoor and outdoor allergies, and for chronic
idiopathic urticaria.

US FDA
Antipsoriatic
Agents
Adalimumab
Humira®
Abbott Laboratories

Approved for the treatment of adults with moderateto-
severe chronic plaque psoriasis, who are not
suitable candidates for other systemic therapies.

US FDA
Calcipotriene 0.005% +
Betamethasone Dipropionate
0.064% Topical Suspension

Taclonex Scalp® / Xamiol® Gel
Warner Chilcott / LEO Pharma

Approved for the once daily treatment of moderateto-
severe psoriasis vulgaris of the scalp in adults 18
years of age or older. It is being marketed as Taclonex
Scalp® (Warner Chilcott) in the US and Xamiol® (Leo
Pharma) in Canada and Europe.

US FDA,
EMEA,
Health
Canada
Calcipotriene 0.005% Topical
Solution

Nycomed US, Inc./ Fougera

Generic formulation approved for the topical
treatment of chronic, moderately severe psoriasis of
the scalp.

US FDA
Etanercept
Enbrel®
Wyeth

Approved in a 50mg once weekly dosage regimen as
an alternative to the currently approved 25mg twice
weekly regimen for the treatment of moderate-tosevere
plaque psoriasis.

EMEA
Ustekinumab
Stelara®
Janssen-Ortho

Approved for adults with moderate-to-severe plaque
psoriasis.

Health
Canada
Crohn’s
Disease
Certolizumab Pegol
Cimzia®
UCB S.A.

Approved for the treatment of adults with moderateto-
severe Crohn’s Disease who are inadequate
responders to conventional therapies.

US FDA
Natalizumab
TYSABRI®
Elan Corp. / Biogen Idec

Approved for inducing and maintaining clinical
response and remission in adult patients with
moderately to severely active Crohn’s Disease (CD)
with evidence of inflammation. Indicated for patients
who are an inadequate responders to, or are able to
tolerate, conventional CD therapies and TNF-alpha
inhibitors.

US FDA
Dermal Filler Hyaluronic Acid Gel + Lidocaine
Prevelle Silk™
Mentor Corporation/Genzyme
Corporation

Approved for the reduction of moderate-to-severe
facial lines, folds, and wrinkles.

US FDA
Hand Eczema Alitretinoin
Toctino®
Basilea Pharmaceuticals

This once daily, oral treatment was approved for
adults with severe, chronic hand eczema that is
unresponsive to potent topical corticosteroids.

Danish
Medicines
Agency,
French
Regulatory
Authority
HIV/AIDS Atazanavir Sulfate
REYATAZ®
Bristol-Myers Squibb

Approved as part of a combination therapy in
treatment naïve HIV-1 infected adult patients. This
300mg once daily formulation to be boosted with
ritonavir 100mg once daily.

US FDA
Etravirine
Intelence™
Tibotec Therapeutics

Approved for the treatment of HIV infected adults
who have failed other antiretroviral therapies. For use
in combination with other antiretroviral agents.

US FDA
Maraviroc
SELZENTRY®
Pfizer

Approved for use in treatment-experienced adults
with CCR5-tropic HIV in combination with other
antiretroviral agents.

US FDA
Tipranavir
Aptivus®
Boehringer-Ingelheim

Approved with dosing information for treatmentexperienced
pediatric patients aged 2-18 years who
are infected with HIV. The recommended dose for
both the capsules and oral solution is 14mg/kg
with 6mg/kg ritonavir, or 375mg/m2 tipranavir
coadministered with 150mg/m2 ritonavir. Prescribers
should calculate the appropriate dose for each child
based on body weight (kg) or body surface area (m2)
and should not exceed the recommended adult dose
of 500mg coadministered with 200mg ritonavir
twice daily.

US FDA
Hypotrichosis Bimatoprost Ophthalmic Solution
LATISSE® 0.03%
Allergan

Approved once daily for hypotrichosis of the
upper eyelashes. To maintain the effect, once daily
continued treatment is required.

US FDA
Vaccines Shingles Vaccine
Zostavax®
Merck Frosst

Approved for the prevention of shingles in individuals
aged 60 years or older.

Health
Canada
HPV Vaccine
Gardasil®
Merck & Co.

An additional indication was approved, including the
prevention of vaginal and vulvar cancer caused by
HPV types 16 and 18 in girls and women aged 9-26
years.

US FDA