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Update on Drugs and Drug News: July-August 2017


Name/Company Approval Dates and Comments

Infliximab-abda for IV infusion
Renflexis®
Samsung Bioepis

In April 2017, the US FDA approved infliximab-abda, a biosimilar referencing Remicade® (infliximab, Janssen), across all eligible indications including the treatment of psoriatic arthritis and adult plaque psoriasis.

Ozenoxacin 1% cream
Ozanex™
Cipher/Ferrer

In May 2017, Health Canada approved ozenoxacin 1% cream, a novel topical antibiotic indicated for the treatment of impetigo in patients aged 2 months and older. It is the first bacteriocidal topical antibiotic that has been shown to be effective against resistant bacteria such as methicillin resistant Staphylococcus aureus (MRSA). Ozenoxacin offers a short 5-day twice-daily dosing regimen and has shown bacteriological eradication as early as day 3 of treatment. Ozenoxacin belongs to a new generation of non-fluorinated quinolones that have demonstrated improved tolerability and safety over fluorinated quinolones. Phototoxicity, photoallergenic sensitization and articular toxicity were not observed in local tolerability studies. This drug also demonstrated in vitro and in vivo antibacterial activity against a broad spectrum of bacteria, including MRSA strains and clinical isolates of organisms with emerging resistance to quinolones and other topical antibiotics.

Standardized allergen extract of house dust mites sublingual tablet
Acarizax®
ALK-Abelló A/S

In May 2017, Health Canada approved this sublingual allergy immunotherapy (SLIT) tablet for the treatment of the signs and symptoms of moderate to severe house dust mite (HDM) allergy. It is formulated as an orally disintegrating tablet designed to rapidly dissolve within seconds under the tongue. The active substance is a standardized allergen extract derived from house dust mites (Dermatophagoides farinae and Dermatophagoides pteronyssinus). Treatment is indicated for adults 18 to 65 years of age with confirmation of positive skin prick test and/or in vitro testing for D. farinae or D. pteronyssinus IgE antibodies. FDA approval was gained in March 2017 and is marketed as Odactra® in the US. Approvals in Europe and Japan under the brand names Acarizax® and Miticure™, respectively, were gained in 2015. In April 2017, Acarizax® had its approval in 12 European countries expanded to include the treatment of adolescent patients with HDM-induced allergic rhinitis.

Doxycycline hyclate immediate release tablet
Mayne Pharma Group

In June 2017, the FDA approved the Abbreviated New Drug Application (ANDA) for doxycycline hyclate immediate release (IR) tablets (75 mg and 150 mg). Doxycycline hyclate IR tablets are a generic version of Acticlate® (Aqua Pharmaceuticals), a tetracyclineclass antibacterial indicated for the treatment of a number of infections, including adjunctive therapy in severe acne.

Device News

UVB Phototherapy System
Clarify™ Home Light Therapy System
Clarify Medical

In June 2017, the FDA granted 510(k) market clearance for this mobile handheld, smartphone-connected phototherapy device for treating various skin conditions. Clarify's proprietary technology allows patients with chronic skin diseases, such as psoriasis, vitiligo, and eczema, to receive narrow-band ultraviolet B (UVB) phototherapy in their homes. A prescription from a doctor is required before using the device. The system consists of a physician web portal, smartphone app and treatment device, which are all wirelessly connected, and in combination allows the doctor to be in control of the treatment protocol, but enables the patient to administer the treatment at the time and place they choose.


In this issue:

  1. Secukinumab in the Treatment of Psoriasis and Psoriatic Arthritis: A Review of the Literature
  2. Hepatitis B and C Viruses and Biologics
  3. Update on Drugs and Drug News - July-August 2017