image of silk fabric and dry skin
Drug ClassGeneric/Trade/
Company Names
IndicationApproving
Regulatory Agency
AcneAdapalene 0.1% lotion
Differin®
Galderma Laboratories
A novel lotion formulation of the retinoid adapalene was approved
for the treatment of acne vulgaris in patients =12 years of age. This
new formulation has been designed to improve tolerable efficacy and
spreads easily. It is available in an easy-to-use pump dispenser and
is indicated for application on the face and other areas of the body
affected by acne.
US FDA
Clindamycin phosphate 1.2%
+ tretinoin 0.025% gel

Veltin™
Stiefel Laboratories, Inc./GSK
This topical combination of an antibiotic with a retinoid in an
aqueous gel vehicle was approved for the treatment of acne vulgaris
in patients =12 years of age.
US FDA
Drospirenone / ethinyl
estradiol / levomefolate
calcium + levomefolate
calcium tablets

Beyaz™

Bayer HealthCare
Pharmaceuticals Inc.
Approval was granted to a new oral contraceptive (OC) to raise folate
levels in women who choose an OC for birth control. The addition of
levomefolate calcium raises folate levels for the purpose of reducing
the risk of a neural tube defect in a pregnancy conceived while
taking Beyaz™ or shortly after discontinuation. The approval of
Beyaz™ is based on Yaz®, which contains the same doses of estrogen
and progestin, and is approved for three indications: prevention
of pregnancy; treatment of symptoms of premenstrual dysphoric
disorder in women who choose an OC for contraception; and
treatment of moderate acne vulgaris in women =14 years of age, but
only if the patient prefers an OC for birth control.
US FDA
Actinic
Keratoses
Imiquimod cream 3.75%
Zyclara™
Graceway Pharmaceuticals
A new formulation of this immune response modifier was
approved for the treatment of clinically typical, visible, or palpable
actinic keratoses. It offers a convenient 6-week dosing cycle and is
indicated for application over larger areas of skin (as compared with
imiquimod 5%), including the full face and balding scalp in adults.
Health Canada
US FDA
Antibacterial
Agents
Ceftaroline fosamil
Teflaro™
Forest Laboratories, Inc.
This novel broad-spectrum injectable cephalosporin antibiotic
was approved for the treatment of community acquired bacterial
pneumonia and complicated skin and skin structure infections.
Ceftaroline has activity against both gram-positive bacteria,
including methicillin-resistant Staphylococcus aureus (MRSA) and
Streptococcus pneumoniae, and common gram-negative pathogens.
US FDA
Daptomycin for injection
Cubicin®
Cubist Pharmaceuticals, Inc.
This antibiotic received an additional indication as the only approved
2-minute IV injection for the treatment of MRSA-complicated skin
infections and bacteremia.
US FDA
CancerCD56-binding monoclonal
antibody (huN901) +
maytansinoid cytotoxic agent
(DM1)

IMGN901
ImmunoGen, Inc.
Orphan drug designation was granted to the IMGN901 compound
(an antibody-drug conjugate) for the treatment of Merkel cell
carcinoma. IMGN901 binds with high affinity to CD56 expressed on
the surface of tumor cells. Once bound, the conjugate is internalized
and the antimitotic agent (DM1) is released.
European Medicines
Agency (EMA)
US FDA
Dermal Fillers
and Injectables
Hyaluronic acid dermal
filler + 0.3% lidocaine

JUVÉDERM®XC
Allergan, Inc.
A new formulation of this hyaluronic acid dermal filler was approved
for the reduction of pain during treatment of moderate to severe
facial wrinkles and folds (i.e., nasolabial folds). The addition of 0.3%
preservative-free lidocaine my also shorten the treatment time by
eliminating the need for an additional anesthetic.
US FDA
Hyaluronic acid dermal filler
+ 0.3% lidocaine

RESTYLANE®-L
PERLANE®-L

Medicis Aesthetics
Additional formulations of these dermal fillers were approved for
the reduction of pain associated with the injectable correction of
moderate to severe nasolabial folds. These products provide patients
with the option of a single syringe containing a wrinkle filler with a
local anesthetic. RESTYLANE®-L is approved for injection into the
mid to deep dermis and PERLANE®-L is approved for implantation
into the deep dermis to superficial subcutis.
US FDA
Lysosomal
Storage
Diseases
Agalsidase alfa

REPLAGAL®

Shire plc
Fast Track designation was granted to this human-cell-line-derived
enzyme replacement therapy for the long-term treatment of Fabry
disease. Therapy is administered every other week by intravenous
infusion.
US FDA
Velaglucerase alfa
VPRIV™
Shire plc
Approval was granted to this hydrolytic lysosomal glucocerebrosidespecific
enzyme for long-term enzyme replacement therapy in
pediatric and adult patients with Type 1 Gaucher disease. Therapy is
administered every other week by intravenous infusion.
European Medicines
Agency (EMA)
US FDA
PsoriasisAdalimumab
Humira®
Abbott Japan Co./Eisai Co.
This fully-human monoclonal anti-TNF- antibody was approved for
the additional indications of plaque psoriasis and psoriatic arthritis.
MHLW (Japan)
Calcipotriene/Calcipotriol
0.005% foam

Sorilux™
Stiefel, a GSK Company
A novel foam formulation of calcipotriene 0.005% was approved for
the topical treatment of mild to moderate plaque psoriasis in patients
=18 years of age. Calcipotriene has been formulated using the
VersaFoam® vehicle, a proprietary delivery technology.
US FDA
Calcitriol ointment
Silkis™
Galderma Canada
Approval was granted to this topical vitamin D3 agent for the
treatment of mild-to-moderate plaque psoriasis in adults. This
product was US FDA approved in 2009 under the trade name of
Vectical™
Health Canada
Psoriatic
Arthritis
Adalimumab
Humira®
Eisai Co., Ltd.
This fully-human monoclonal anti-TNF- antibody was approved for
the additional indications of plaque psoriasis and psoriatic arthritis.
MHLW (Japan)
VaccinesHuman papillomavirus
quadrivalent (Types 6, 11, 16,
and 18) recombinant vaccine

Gardasil®
Merck & Co., Inc.
An additional indication was granted to this human papillomavirus
(HPV) vaccine for the prevention of infection caused by HPV types 6,
11, 16 and 18 and genital warts caused by HPV types 6 and 11 in boys
and men 9-26 years of age.
Health Canada
This HPV recombinant vaccine received an additional approved
indication for the prevention of anal cancer caused by HPV types 16
and 18 and for the prevention of anal intraepithelial neoplasia (AIN)
grades 1, 2 and 3 (anal dysplasias and precancerous lesions) caused
by HPV types 6, 11, 16 and 18, in males and females 9-26 years of age.
US FDA
Wound CareSmall molecule oxychlorine
compound

Microcyn® Skin and Wound
HydroGel

Oculus Innovative Sciences
New dermatology indications were granted to Microcyn® Skin
and Wound HydroGel. This prescription product is intended for
use, under the supervision of a healthcare professional, in the
management of wounds, including itch and pain relief associated
with skin irritation, sores, injuries, and ulcers of dermal tissue.
US FDA
OtherCollagenase clostridium
histolyticum

XIAFLEX™
Auxilium Pharmaceuticals
This novel first-in-class, orphan-designated biologic was approved
for the treatment of Dupuytren’s contracture in adults with a palpable
cord. The injected enzymes dissolve and weaken the contracted
collagen cord. This new treatment represents the only nonsurgical
option for Dupuytren’s disease.
US FDA
Polidocanol injection
Asclera®
BioForm Medical Inc./
Chemische Fabrik Kreussler
& Co.
Regulatory approval was granted to this sclerotherapy agent to
improve the appearance of varicose veins. The injection treatment is
used to close spider veins ( veins (1-3 millimeters in diameter). The agent acts by damaging the
cell lining of blood vessels, causing the vessels to close, and leading to
subsequent replacement by other types of tissue.
US FDA