| Name/Company | Approval Dates and Comments |
Peginterferon alfa-2b Sylatron™ | 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 Perrigo Company | 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 Taro Pharmaceutical Industries Ltd. | 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). |
Famciclovir tablets 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 Actavis Group | 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. |
