|Name/Company||Approval Dates and Comments|
The US FDA granted orphan drug designation in March 2010 to the IMGN901 compound (an antibody-drug conjugate) for the treatment of Merkel cell carcinoma (MCC). Through a separate process, the European Union’s Committee for Orphan Medicinal Products (COMP) also granted IMGN901 orphan medicinal product designation for the treatment of MCC. IMGN901 binds with high affinity to CD56 expressed on the surface of tumor cells. Once bound, the conjugate is internalized and the antimitotic agent (DM1) is released.
Oculus Innovative Sciences
The US FDA granted clearance for new dermatology indications in March 2010 to Microcyn® Skin and Wound HydroGel. This prescription product is intended for use, under the supervision of a healthcare professional, in the management of wounds, including itch and pain relief associated with skin irritation, sores, injuries, and ulcers of dermal tissue.
Moberg Derma AB (Sweden)
Medical Futures Inc. (Canada)
In April 2010, marketing authorization in the European Union was granted to this nonprescription topical solution for the treatment of discolored and damaged nails (e.g., caused by onychomycosis or nail psoriasis). Application is once-daily on affected nails and improvements can be seen within 2-4 weeks of treatment. The product is based on the Kaprolac® principle, which is a patented composition of well-known dermatologic compounds.
In April 2010, Bayer HealthCare announced that it has changed the labeling information for Yaz® and Yasmin® (drospirenone + ethinyl estradiol) to state that the risks of venous thrombosis associated with the drugs are similar to those reported with other oral contraceptives. The label changes were coordinated with the US FDA and are based on data gathered from studies involving over 120,000 women. A similar amendment took place in the European Union for an updated label of Yasmin® to reflect a similar risk profile.
In April 2010, the US FDA announced that it is reviewing the safety of triclosan. In an online consumer update, the agency advised it is investigating recent studies that demonstrate repeated heavy use of this chemical can alter hormone regulation in some animals. Other studies suggest the chemical promotes bacterial resistance to antibiotics (e.g., methicillin-resistant Staphylococcus aureus). The FDA currently has no evidence that triclosan is hazardous to humans and is not recommending consumer avoidance. However, the agency states that there is an absence of data supporting triclosan-containing products are more effective than soaps without this antimicrobial agent. Earlier this year, the European Union instituted a ban on triclosan from any products that may come into contact with food. More information is available at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm205999.htm.