|Name/Company||Approval Dates and Comments|
Centocor Ortho Biotech
The US FDA approved this biologic in September 2009 for the treatment of moderate-to-severe plaque psoriasis in adults ≥18 years of age. Ustekinumab is a first-in-class human monoclonal antibody that selectively targets the cytokines interleukin-12 and interleukin-23. Administration is by subcutaneous injection at Weeks 0 and 4, then every 12 weeks thereafter.
The US FDA approved this histone deacetylase inhibitor in November 2009 for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. Romidepsin is administered intravenously over a 4-hour period on days 1, 8, and 15 of a 28-day cycle. Cycles are repeated every 28 days if the patient continues to benefit from and tolerate the treatment.
The US FDA issued a warning letter to Galderma Laboratories expressing concern that 2 visual aids (TRI-486 and TRI-487) for Tri-Luma® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) have suggested uses that have not been approved by the FDA, thus creating new “intended uses” for the drug. Moreover, these unapproved uses lack adequate directions, broaden the indication for Tri-Luma®, and omit and minimize important risk information for this drug. These visual aids also contain unsubstantiated claims that significantly overstate its efficacy, thereby misbranding the drug. Tri-Luma® was approved in January 2002 for the short-term treatment of moderate-to-severe melasma of the face in the presence of measures for sun avoidance, including the use of sunscreens. Galderma has been asked to immediately cease the dissemination of these promotional materials and the unapproved product labeling. The FDA has asked Galderma to submit a plan of action to disseminate truthful, non-misleading, and corrective messages.
The US FDA issued a warning letter to Allergan expressing concern about a journal advertisement for Aczone® (dapsone) gel 5%. This journal advertisement has been deemed false or misleading because it overstates the efficacy of Aczone® and omits material facts and important risk information associated with product usage, thereby misbranding this drug. Allergan has been asked to immediately cease the dissemination of violative promotional material and to submit a plan of action to disseminate truthful, non-misleading, and complete corrective messages. Aczone® is indicated for the topical treatment of acne vulgaris.
The US FDA, Health Canada, and Roche/Hoffmann-La Roche have notified healthcare professionals that cases of pure red cell aplasia have been reported in patients treated with mycophenolate mofetil (CellCept®). Forty-one cases of this condition have been reported. Some patients were also receiving other immunosuppressive medications (i.e., alemtuzumab, tacrolimus, and azathioprine) that could have contributed to the development of this disease. In 16 of the reported cases, reduction or discontinuation of the mycophenolate mofetil dosage led to resolution of this condition. The Warnings and Adverse Reactions sections of the CellCept® Prescribing Information have been revised to reflect this new safety information.