|Name/Company||Approval Dates and Comments|
Tedizolid phosphate tablets and IV injection
In June 2014, the US FDA approved tedizolid, a novel oxazolidinone-class antibacterial agent, indicated for treatment of adult acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).
Hyaluronic acidbased dermal filler
In June 2014, FDA marketing clearance was granted for Restylane® Silk injectable gel with 0.3% lidocaine, a device indicated for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21.
Galderma R&D, LLC
In June 2014, the FDA granted Orphan Drug Designation to trifarotene for the treatment of congenital ichthyosis, a rare inherited skin scaling disorder.
Icatibant SC injection
In June 2014, Health Canada issued a Notice of Compliance for icatibant acetate ready-to-use injection for the treatment of acute attacks of hereditary angioedema (HAE) in adults with C1-esterase inhibitor deficiency via blockade of bradykinin at the bradykinin B2 receptor.
C1 esterase inhibitor
In July 2014, the FDA approved the first recombinant human C1 esterase inhibitor for the treatment of acute angioedema attacks in adult and adolescent patients with HAE. This IV infused treatment can be administered by the patient after receiving training by a healthcare provider.
Methotrexate SC injection
In July 2014, the FDA approved this SC injectable methotrexate therapy delivered in an auto-injector for rheumatoid arthritis (RA), polyarticular-course juvenile idiopathic arthritis (pJIA), and psoriasis. Ten dosage strengths will be available.
Tavaborole 5% topical solution
In July 2014, the FDA approved tavaborole, the first oxaborole antifungal agent approved for the topical treatment of onychomycosis of the toenails caused by Trichophyton rubrum or Trichophyton mentagrophytes. This clear, colorless, alcoholbased solution is applied with a dropper to the infected toenail once daily for 48 weeks.
Nivolumab IV infusion
In July 2014, the Ministry of Health, Welfare and Labor (Japan) granted manufacturing and marketing approval to this PD-1 monoclonal antibody for the treatment of unresectable melanoma. The drug is the first human PD-1 monoclonal antibody to gain regulatory approval.
Doxycycline hyclate tablets
In July 2014, the FDA approved this tetracycline-class antimicrobial agent indicated for a number of infections including adjunctive therapy in severe acne. Several dosing options are available with film-coated round 75 mg tablets and oval-shaped dual-scored 150 mg tablets.
In July 2014, Galderma Canada announced regulatory approval for the expanded use of adapalene 0.1% + benzoyl peroxide 2.5% topical gel to include the treatment of acne vulgaris in patients ≥9 years of age. This new indication also coincides with a name change from Tactuo™ to TactuPump™and a new 70 g pump delivery system.
In July 2014, Health Canada’s Natural Health Products Directorate approved DispersinB® skin cream and DispersinB® shampoo (Kane Biotech Inc.). Both products are antibiofilm-antimicrobial and antibiotic-free formulations that have anti-inflammatory and anti-pruritic effects.