Regulatory and Washington

PARSIPPANY, N.J. — The Food and Drug Administration has approved a topical treatment made by Leo Pharma for a skin condition that can lead to cancer, the drug maker said Wednesday.

Leo announced the FDA approval of Picato (ingenol mebutate) gel in the 0.015%/0.05% strength for actinic keratosis, also known as AK, which is a precancerous condition resulting from cumulative sun exposure that has the potential to lead to squamous cell carcinoma.

ATLANTA — Leg and foot amputations among patients diagnosed with diabetes saw a dramatic decline between 1996 and 2008, thanks to improvements in blood-sugar control, foot care and diabetes management, along with declines in cardiovascular disease, according to a new study conducted by the Centers for Disease Control and Prevention.

PARSIPPANY, N.J. — Watson Pharmaceuticals has acquired the Australia and Southeast Asia generic pharmaceutical business of Strides Arcolab for $392.4 million in cash.

CAMBRIDGE, Mass. — The Food and Drug Administration has approved a new means of administering a cancer drug made by Takeda, the drug maker said.

The FDA approved injection under the skin of Velcade (bortezomib) for multiple myeloma and mantle-cell lymphoma, also known as subcutaneous injection.

Takeda said the approval was based on results of a phase-3 trial conducted on 222 patients who had not received the drug before that showed subcutaneous injection worked as well as intravenous injection.

CAMBRIDGE, Mass. — The Food and Drug Administration has approved a new manufacturing plant that will be operated by drug maker Genzyme.

Genzyme said the plant, located in Framingham, Mass., will help the company continue the production of Fabrazyme (agalsidase beta), a Fabry disease treatment, so that patients can be return to the full dosing levels (1 mg/kg).

SUPPLIER NEWS — The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said. The FDA announced the approval of a single REMS for transmucosal immediate-release fentanyl drugs. The new system, which takes effect in March, will allow prescribers and pharmacies to enroll into one system instead of individual systems for each product.

SUNBURY, Pa. — Weis Markets on Monday announced it has joined the SmartWay Transport Partnership, a U.S. Environmental Protection Agency program that will help the grocer assess the environmental impact and energy efficiency of the trucks supplying its 161 stores.

ALLEGAN, Mich. — Perrigo is seeking approval from the Food and Drug Administration for a drug used to treat allergies in adolescents and adults, the company said Monday.