Name/CompanyApproval Dates/Comments
Dalbavancin hydrochloride for IV infusion
Cipher Pharmaceuticals
Health Canada approved this antibiotic in September 2018 for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. Xydalba™ is the first bactericidal, single-dose IV therapy effective against resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) causing skin and soft tissue infections, including cellulitis/erysipelas, major cutaneous abscesses, and wound infections.
Omadacycline for IV and oral use
Paratek Pharmaceuticals
In October 2018, the US FDA approved omadacycline, a tetracycline antibiotic, for the treatment of adults with community-acquired bacterial pneumonia and ABSSSI. This once-daily IV and oral antibiotic exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypical bacteria, and drug resistant strains.
Tildrakizumab-asmn for SC injection
Sun Pharmaceutical Industries
The FDA approved tildrakizumab-asmn, an interleukin-23 (IL-23) inhibitor, in October 2018 for the treatment of moderateto-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Tildrakizumab-asmn is a humanized lgGI/k monoclonal antibody designed to selectively bind to the p19 subunit of IL-23 and inhibit its interaction with the IL-23 receptor.
Adalimumab-adaz for SC injection
In October 2018, the FDA granted marketing authorization for Hyrimoz™, a biosimilar to Humira® (adalimumab, AbbVie), as an approved treatment for rheumatoid arthritis, juvenile idiopathic arthritis in patients aged ≥4 years of age, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. Due to the terms of intellectual property-related litigation with AbbVie, this drug will not be commercially available in the US until September 30, 2023.
Halobetasol propionate 0.01% lotion
Bausch Health
This new formulation of halobetasol propionate received final approval from the FDA in November 2018 for the topical treatment of plaque psoriasis in adult patients. Bryhali™ is a new potent to superpotent corticosteroid in a novel vehicle lotion with safety established for dosing up to 8 weeks.
Hyaluronic acid dermal filler
Restylane® Lyft
Galderma Laboratories
In November 2018, the FDA approved the use of Restylane® Lyft, a hyaluronic acid (HA) dermal filler, with a small blunt tip cannula for cheek augmentation and correction of age-related midface contour deficiencies in patients aged >21 years.
Pembrolizumab for IV infusion
Merck & Co.
The FDA granted accelerated approval to pembrolizumab, an anti-PD-1 immunotherapy, in December 2018 for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). Approval was based on Cancer Immunotherapy Trials Network protocol 9 (CITN-09), also known as KEYNOTE-017 (NCT02267603), which included 50 patients with recurrent locally advanced or metastatic MCC who had not previously received systemic therapy for advanced disease. Patients were administered 2 mg/kg pembrolizumab every 3 weeks. The overall response rate was 56% (95% CI, 41-70), which included a 24% complete response rate. Median duration of response had not been reached. Among 28 responders, 96% responded for longer than 6 months and 54% responded for longer than 12 months.

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