| Name/Company | Approval Dates/Comments |
| Dalbavancin hydrochloride for IV infusion Xydalba™ 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 Nuzyra™ 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 Ilumya™ 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 Hyrimoz™ Sandoz/Novartis |
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 Bryhali™ 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 Keytruda® 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. |
