FDA Approved Drugs for Dermatology Drugs Approved in 2019

FDA Approved Drugs for Dermatology

Drugs Approved in 2019:

 

Duobrii (halobetasol propionate and tazarotene) ; Ortho Dermatologics; For the treatment of plaque psoriasis , Approved April 2019

Jeuveau (prabotulinumtoxinA-xvfs); Evolus; For the improvement of glabellar lines, Approved February 2019

Skyrizi (risankizumab-rzaa) ; AbbVie; For the treatment of plaque psoriasis, Approved April 2019

Drugs Approved in 2018:

Braftovi (encorafenib) + Mektovi (binimetinib); Array BioPharma; For the treatment of unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, Approved June 2018

Cimzia (certolizumab pegol) ; UCB; For the treatment of moderate-to-severe plaque psoriasis, Approved May 2018

Ilumya (tildrakizumab-asmn); Sun Pharmaceuticals; For the treatment of plaque psoriasis , Approved March 2018

Keytruda (pembrolizumab); Merck; For the treatment of Merkel cell carcinoma, Approved December 2018

Libtayo (cemiplimab-rwlc); Regeneron Pharmaceuticals; For the treatment of cutaneous squamous cell carcinoma, Approved September 2018

Nuzyra (omadacycline) ; Paratek Pharmaceuticals; For the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections, Approved October 2018

Qbrexza (glycopyrronium) ; Dermira; For the treatment of primary axillary hyperhidrosis, Approved June 2018

Rituxan (rituximab); Biogen IDEC, Genentech; For the treatment of Pemphigus Vulgaris , Approved June 2018

Seysara (sarecycline) ; Paratek Pharmaceuticals; For the treatment of moderate to severe acne vulgaris in patients 9 years of age and older., Approved October 2018

 

Drugs Approved in 2017:

Bavencio (avelumab) ; EMD Serono/Pfizer; For the treatment of Merkel cell carcinoma , Approved March 2017

Baxdela (delafloxacin) tablets and injection; Melinta Therapeutics; For the treatment of acute bacterial skin and skin structure infections, Approved June 2017

Dupixent (dupilumab); Regeneron Pharmaceuticals; For the treatment of atopic dermatitis, Approved March 2017

Eskata (hydrogen peroxide); Aclaris Therapeutics; For the treatment of seborrheic keratoses, Approved December 2017

Imbruvica (ibrutinib); Pharmacyclics; For the treatment of chronic graft-versus-host disease, Approved August 2017

Rhofade (oxymetazoline hydrochloride); Allergan; For the treatment of facial erythema associated with rosacea, Approved January 2017

Siliq (brodalumab); Valeant Pharmaceuticals; For the treatment of plaque psoriasis , Approved February 2017

Tremfya (guselkumab); Janssen Biotech; For the treatment of moderate-to-severe plaque psoriasis, Approved July 2017

Xepi (ozenoxacin) ; Medimetriks; For the treatment of impetigo, Approved December 2017

Drugs Approved in 2016:

Ameluz (aminolevulinic acid hydrochloride); Biofrontera Pharma; For the treatment of actinic keratoses, Approved May 2016

Eucrisa (crisaborole) ointment; Pfizer; For the treatment of atopic dermatitis, Approved December 2016

Taltz (ixekizumab); Eli Lilly; For the treatment of plaque psoriasis and active psoriatic arthritis, Approved March 2016

Drugs Approved in 2015

Cosentyx (secukinumab); Novartis; For the treatment of plaque psoriasis, Approved January 2015

Cotellic (cobimetinib) ; Genentech; For the treatment of BRAF V600E or V600K melanoma, Approved November 2015

Enstilar (calcipotriene and betamethasone dipropionate); LEO Pharmaceuticals; For the treatment of psoriasis, Approved October 2015

Imlygic (talimogene laherparepvec) ; Amgen; For the treatment of unresectable recurrent melanoma, Approved October 2015

Kybella (deoxycholic acid); Kythera Biopharma; For the treatment of submental fat, Approved April 2015

Odomzo (sonidegib); Novartis; For the treatment of locally advanced basal cell carcinoma, July 2015

Drugs Approved in 2014:

Dalvance (dalbavancin); Durata Therapeutics; For the treatment of acute bacterial skin and skin structure infections, Approved May 2014

Jublia (efinaconazole) 10% topical gel; Valeant Pharmaceuticals; For the treatment of onychomycosis of the toenails, Approved June 2014

Kerydin (tavaborole); Anacor; For the treatment of onychomycosis of the toenails, Approved July 2014

Keytruda (pembrolizumab); Merck; For the treatment of unresectable or metastatic melanoma, Approved September 2014

Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of unresectable or metastatic melanoma, Approved December 2014

Orbactiv (oritavancin); The Medicines Company; For the treatment of acute bacterial skin and skin structure infections, Approved August 2014

Otezla (apremilast); Celgene; For the treatment of moderate to severe plaque psoriasis, Approved September 2014

Sivextro (tedizolid phosphate) ; Cubist Pharmaceuticals; For the treatment of acute bacterial skin and skin structure infections, Approved June 2014

Soolantra (ivermectin) cream, 1%; Galderma Labs; For the treatment of inflammatory lesions of rosacea, Approved December 2014

Drugs Approved in 2013:

Luzu (luliconazole) Cream 1%; Valeant Pharmaceuticals; For the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis, November of 2013

Mekinist (trametinib); GlaxoSmithKline; For the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations, Approved May of 2013

Mirvaso (brimonidine); Galderma Labs; For the treatment of facial erythema of rosacea, Approved August 2013

Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes labialis in adults, Approved April 2013

Tafinlar (dabrafenib); GlaxoSmithKline; For the treatment of unresectable or metastatic melanoma with BRAF V600E mutation, Approved May 2013

Valchlor (mechlorethamine) gel; Ceptaris Therapeutics; For the treatment of Stage IA/IB mycosisfungoides-type cutaneous T-cell lymphoma, Approved August 2013

Varithena (polidocanol injectable foam); BTG plc; For the treatment of varicose veins, November 2013

Drugs Approved in 2012:

Erivedge (vismodegib); Genentech; For the treatment of basal cell carcinoma, Approved January 2012

Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of postherpetic neuralgia, Approved June 2012

Picato (ingenol mebutate) gel; LEO Pharma; For the treatment of actinic keratosis, Approved January 2012

Sklice (ivermectin) lotion; Sanofi Pasteur; For the treatment of head lice, Approved February 2012

Drugs Approved in 2011:

Firazyr (icatibant); Shire Pharmaceuticals; For the treatment of acute attacks of hereditary angioedema, Approved August of 2011

Gralise (gabapentin); Abbott Laboratories; For the treatment of postherpetic neuralgia, Approved February 2011

laViv (azficel-T); Fibrocell Science; For the improvement of nasolabial fold wrinkles in adults, Approved June 2011

Sylatron (peginterferon alfa-2b); Merck; For the treatment of melanoma, Approved April 2011

Yervoy (ipilimumab); Bristol-Myers Squibb; For the treatment of metastatic melanoma, Approved March 2011

Zelboraf (vemurafenib); Roche; For the treatment of BRAF + melanoma, Approved August of 2011

Drugs Approved in 2010:

Teflaro (ceftaroline fosamil); Cerexa; For the treatment of bacterial skin infections and bacterial pneumonia, November 2010

Veltin (clindamycin phosphate and tretinoin); Stiefel; For the treatment of acne vulgaris, Approved July 2010

Zyclara (imiquimod); Graceway; For the treatment of actinic keratoses of the face and scalp, Approved March 2010

Drugs Approved in 2009:

 

Stelara (ustekinumab); Janssen Biotech; For the treatment of plaque psoriasis, psoriatic arthritis and Crohn’s disease, Approved September 2009

Vibativ (telavancin); Theravance; For the treatment of complicated skin and skin structure infections, Approved September 2009

Drugs Approved in 2007

Altabax (retapamulin); GlaxoSmithKline; For the treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes, Approved April 2007

Extina (ketoconazole); Stiefel; For the treatment of seborrheic dermatitis, Approved June 2007

Xyzal (levocetirizine dihydrochloride); UCB; For the treatment of seasonal and perennial allergic rhinitis and urticaria, Approved May 2007

Drugs Approved in 2006

Desonate (desonide); Dow Pharm; For the treatment of atopic dermatitis, Approved October 2006

Verdeso (desonide); Connetics Corporation; For the treatment of atopic dermatitis, Approved September 2006

Drugs Approved in 2005

Tygacil (tigecycline); Wyeth; For the treatment of complicated skin and skin structure and intra-abdominal infections and bacterial pneumonia, Approved 2005

Drugs Approved in 2003

Amevive (alefacept); Biogen IDEC; For moderate to severe chronic plaque psoriasis., Approved January 2003

Finacea (azelaic acid) Gel, 15%; Berlex Laboratories; Gel formulation for the treatment of rosacea., January 2003

Drugs Approved in 2002

Botox Cosmetic (botulinum toxin type A); Allergan; For the temporary improvement in the appearance of glabellar lines (brow furrow), Approved April 2002

Drugs Approved in 2001

Elidel; Novartis; Topical cream for the treatment of atopic dermatitis, Approved December 2001

Estrostep (norethindrone acetate and ethinyl estradiol); Pfizer; For the treatment of moderate acne vulgaris, Approved July 2001

Finevin; Berlex Laboratories; Topical cream for the treatment of mild to moderate inflammatory acne vulgaris, Approved May 2001

Invanz; Merck; Once-daily injectable treatment for bacterial infections, Approved November 2001

Lamisil Solution, 1%; Novartis; Topical treatment for tinea (pityriasis) versicolor, althete’s foot, jock itch, and ringworm, Approved March 2001

Drugs Approved in 2000

Benzamycin (erythromycin 3%-benzoyl peroxide 5% topical gel); Dermik Laboratories; For the topical treatment of acne vulgaris, Approved November 2000

Cefazolin and Dextrose USP; B Braun Medical; Respiratory tract infections, Approved July 2000

Chloraprep (chlorhexidine gluconate); MEDI FLEX HOSP PRODUCTS; For use as a patient preoperative skin preparation, Approved July 2000

Clindamycin phosphate topical gel; Target Research Associates; For once a day treatment of acne vulgaris, Approved November 2000

Lamisil (terbinafine hydrochloride) Solution, 1%; Novartis; For the treatment of athlete’s foot, jock itch and ringworm, Approved March 2000

Protopic (tacrolimus) ointment; Fujisawa Healthcare; For short-term and intermittent long-term treatment of moderate to severe atopic dermatitis, Approved December 2000

Skin Exposure Reduction Paste Against Chemical Warfare Agents (SERPACWA); US Army Medical Research, Material Command; To reduce absorption of chemical warfare agents through the skin, Approved February 2000

Drugs Approved in 1999

Lamisil (terbinafine hydrochloride) Dermagel, 1%; Novartis; Treatment for tinea pedis (athlete’s foot), Approved March 1999

Luxiq (betamethasone valerate) Foam; Connetics Corporation; Treatment for dermatoses of scalp, Approved June 1999

Drugs Approved in 1998

Dynabac; Sanofi-aventis; Treatment for acute bacterial exacerbations (chronic bronchitis and skin infections), Approved March 1998

Lustra; Medicis Pharmaceutical; Treatment for ultraviolet-induced skin discolorations, Approved January 1998

MetroLotion; Galderma Laboratories; Treatment of inflammatory papules and pustules of rosacea, Approved November 1998

Noritate; Dermik Laboratories; Treatment for rosacea, Approved January 1998

Salagen Tablets; MGI Pharma; Treatment for Sjogren’s Syndrome, Approved February 1998

Sulfamylon; Mylan Laboratories; Treatment used to control bacterial infections on excised burn wounds, Approved June 1998

Thalomid; Celgene; Treatment for moderate to severe erythema nodosum leprosum (ENL), Approved July 1998

Drugs Approved in 1997

Avita Gel; Penederm; Treatment for acne, Approved January 1997

Bactroban Cream; SmithKline Beecham; Treatment for secondarily infected traumatic skin lesions, Approved December 1997

Clindamycin Phosphate Topical Solution USP 1%; Morton Grove Pharmaceuticals; Generic equivalent of CLEOCIN Topical Solution 1%, Approved July 1997

Condylox Gel 0.5% (pokofilox); Oclassen Pharmaceuticals; Treatment for external genital and perianal warts, Approved March 1997

Dermagraft-TC; Advanced Tissue Sciences; Treatment for partial-thickness and severe burns, Approved October 1997

Klaron (sodium sulfacet amide lotion ) Lotion, 10%; Dermik Laboratories; Treatment for adult acne, Approved February 1997

Mentax (1% butenafine HCl cream); Penederm; Treatment for athlete’s foot, Approved December 1997

Mentax (1% butenafine HCl cream); Penederm; Treatment for tinea corporis (ringworm) and tinea cruris (groin fungus), Approved January 1997

Minoxidil Topical Solution 2% for Women; Alpharma; Generic equivalent of Rogaine, Approved April 1997

Omnicef; Warner-Lambert; Treatment against various bacterias, Approved December 1997

Ortho Tri-Cyclen Tablets (norgestimate/ethinyl estradiol); Ortho-McNeil Pharmaceutical; Treatment for acne in women seeking contraception, Approved January 1997

Propecia; Merck; Treatment for male baldness, Approved December 1997

REGRANEX (becaplermin) Gel; RW Johnson; Treatment for diabetic foot ulcers, Approved December 1997

 

Retin-A Micro (tretinoin gel) microsphere, 0.1%; Advanced Polymer Systems; Treatment for acne, Approved February 1997

 

Tazorac topical gel; Allergan; Treatment for Psoriasis, Acne Vulgaris, Approved June 1997

Drugs Approved in 1996

 

Differin (adapalene gel) Gel, 0.1%; Galderma Laboratories; Treatment for acne, Approved June 1996

 

Iamin; ProCyte; Gel wound dressing, Approved February 1996

 

Iontocaine; Iomed; Needle-free anesthetic, Approved May 1996

 

IvyBlock; EnviroDerm Pharmaceuticals; Treatment for poison ivy, poison oak, and poison sumac, Approved September 1996

Drugs Approved in 1995

Renova (tretinoin emollient cream); Johnson & Johnson; Treatment for facial wrinkles, brown spots, and surface roughness associated with chronic sun exposure, Approved December 1995