Regulatory and Washington

WASHINGTON — After President Barack Obama delivered his State of the Union address on Tuesday night, the National Retail Federation issued a response regarding his remarks on job creation.

NRF said it welcomed the President's emphasis on job creation, saying that it will help restore the nation's economic state.

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.

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).

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.

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.

PARSIPPANY, N.J. — A panel of experts at the Food and Drug Administration has declined to recommend approval for a topical drug for preventing premature birth in pregnant women, the drug's manufacturers said.

Columbia Labs and Watson Pharmaceuticals announced that the FDA's Reproductive Health Drugs Advisory Committee did not recommend approval for progesterone vaginal gel in the 8% strength. The drug is designed to reduce the risk of preterm birth in women with short uterine cervical length in the middle trimester of pregnancy.

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.