|Name/Company||Approval Dates and Comments|
The US FDA approved peginterferon alfa-2b in March 2011 to treat node-positive melanoma after surgical resection. Therapy is administered subcutaneously (may be self-injected) and is indicated as an adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection. The recommended dosing is 6 mcg/kg/week subcutaneously for 8 doses, followed by 3 mcg/kg/week subcutaneously for up to 5 years. A clinical investigation showed that patients who received the drug delayed cancer recurrence by approximately 9 additional months. One-third of peginterferon alfa-2b-treated patients ceased therapy due to adverse effects.
The US FDA approved this immune response modifier in March 2011 for the topical treatment of external genital warts and perianal warts in patients ≥12 years of age. Under clinical investigation, Zyclara® showed that the once-daily treatment regimen for up to 8 weeks was safe and provided sustained efficacy. Only 15% of imiquimodtreated patients with complete clearance experienced recurrence 12 weeks after therapy.
Health Protection Branch (HPB) of Health Canada approved a novel once-daily retinoid + benzoyl peroxide combination gel in March 2011 for the treatment of mild to moderate acne vulgaris in patients ≥12 years of age. The product is marketed in the US under the trade name of Epiduo®, which was FDA approved in December 2008.
The European Medicines Agency (EMA) approved this novel, first-in-class biologic in March 2011 for the treatment of Dupuytren’s contracture in adults with a palpable cord. The injected enzymes dissolve and weaken the contracted collagen cord. It is the only nonsurgical option for Dupuytren’s disease.
|Generic Drug Update|
Minoxidil 5% foam
The US FDA approved a generic version of OTC minoxidil foam in May 2011 for hair regrowth (innovator brand Men’s Rogaine® Foam, McNeil-PPC, Inc.).
Imiquimod 5% cream
The US FDA approved a generic version of imiquimod 5% cream in April 2011 for the topical treatment of actinic keratoses on the face or scalp, superficial basal cell carcinoma, and external genital and perianal warts in patients ≥12 years of age (innovator brand Aldara® 5% cream, Graceway Pharmaceuticals).
Mylan Pharmacetuicals, Inc.
A generic formulation of famciclovir (innovator brand Famvir®, Novartis Pharmaceuticals) was launched in April 2011 for the treatment of herpes zoster (shingles).
Valacyclovir hydrochloride tablets
The US FDA has granted approval to Actavis Group in March 2011 to market its generic version of GlaxoSmithKline’s antiviral product valacyclovir hydrochloride (Valtrex®) tablets for the treatment of herpes zoster and genital herpes.