Lebrikizumab SC injection
Company: Dermira, Inc.
Approval Dates/Comments: In December 2019, the US FDA granted Fast Track designation for lebrikizumab, a novel investigational therapy under evaluation for the treatment of moderate-to-severe atopic dermatitis. Lebrikizumab is a humanized monoclonal antibody designed to target interleukin (IL)-13, an important mediator of inflammation.
Infliximab-axxq for IV injection
Trade Name: Avsola™
Approval Dates/Comments: The FDA approved this anti-TNF-alpha monoclonal antibody in December 2019 for all approved indications of the reference product, Remicade® (infliximab), including chronic severe plaque psoriasis and psoriatic arthritis.
Methotrexate for SC injection
Trade Name: RediTrex™
Approval Dates/Comments: In December 2019, the FDA approved RediTrex™, a folate analog metabolic inhibitor indicated for the management of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and psoriasis.
Trifarotene cream 50 mcg/g
Trade Name: Aklief®
Approval Dates/Comments: Health Canada approved trifarotene cream 50 mcg/g in November 2019 for the topical treatment of acne of the face and/or trunk in patients ≥12 years of age. Aklief® is the first new retinoid molecule to receive Health Canada approval for the treatment of acne in more than 20 years. It is the only topical retinoid that selectively targets retinoic acid receptor (RAR) gamma, the most common RAR found in the skin. This is the first topical treatment shown to treat both facial and truncal acne.
Adalimumab-afzb for SC injection
Trade Name: Abrilada™
Company: Pfizer Inc.
Approval Dates/Comments: In November 2019, the FDA approved adalimumab-afzb, a biosimilar to Humira® (adalimumab), for the treatment of multiple chronic inflammatory diseases, including psoriatic arthritis and plaque psoriasis.
Lidocaine + tetracaine (7%/7%) local anesthetic cream
Trade Name: Pliaglis®
Company: Crescita Therapeutics
Approval Dates/Comments: The FDA approved an enhanced formulation of Pliaglis® in November 2019. The enhancements include improved application and removal properties. Pliaglis®, a lidocaine and tetracaine (7%/7%) formulation, is a prescription topical anesthetic cream that provides local dermal anesthesia on intact skin prior to superficial dermatological procedures.
Maralixibat oral solution
Company: Mirum Pharmaceuticals
Approval Dates/Comments: The FDA granted Breakthrough Therapy designation in October 2019 for maralixibat, an oral, minimally absorbed, selective inhibitor of apical sodium-dependent bile acid transporter, for the treatment of pruritus associated with Alagille syndrome (ALGS) in patients aged 1 year or older. Signs and symptoms arising from liver damage in ALGS may
include jaundice, pruritus and xanthomas.
Cetirizine hydrochloride for IV injection
Trade Name: Quzyttir™
Company: TerSera Therapeutics
Approval Dates/Comments: The FDA approved cetirizine hydrochloride for intravenous injection in October 2019 to treat acute urticaria in adults and children 6 months of age and older. This is the first IV formulation of the histamine-1 (H1) receptor antagonist cetirizine.
Minocycline foam 4%
Trade Name: Amzeeq™
Approval Dates/Comments: In October 2019, the FDA approved a novel preparation of minocycline 4% topical foam for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients ≥9 years of age. This is the first topical minocycline formulation approved by the FDA for any condition.