Regulatory and Washington

BEDMINSTER, N.J. — The Food and Drug Administration has approved a drug made by Archimedes Pharma for treating breakthrough pain in cancer patients, Archimedes said last week.

Archimedes announced the approval of Lazanda (fentanyl) nasal spray for cancer patients who have acquired a tolerance to opioid drugs. Breakthrough pain is an intense, sudden pain that is unpredictable and often debilitating and occurs despite otherwise appropriate pain therapy.


The sun care segment is in the midst of some significant changes as, years after announcing its intent to improve the labeling of sunscreens, the Food and Drug Administration finally has issued new rules for OTC sunscreen products. For consumers, it should mean less confusion when buying products. For manufacturers, it will mean ensuring that they meet the new labeling and testing requirements.


WASHINGTON — The Food and Drug Administration on Tuesday published long-awaited guidance on new dietary ingredients in the Federal Register.

ATLANTA — New graphic cigarette warning labels released last month by the Food and Drug Administration already appear to be having one desired effect: an increase in "quit smoking" queries to the national 1-800-QUIT-NOW smoking cessation line, the Associated Press reported Saturday.

The new labels aren’t even on cigarette packages yet — the labels will be implemented next year.

RARITAN, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating deep vein thrombosis in patients undergoing knee or hip replacement surgery, a J&J subsidiary said Friday.

Janssen Pharmaceuticals announced the approval of Xarelto (rivaroxaban) tablets as a once-daily oral anticoagulant for DVT, a condition that could lead to pulmonary embolism.

SCHAUMBURG, Ill. — Sagent has received approval from the Food and Drug Administration for its antibacterial drug.

The drug maker said that the FDA approved polymyxin B for injection USP. Sagent said that polymyxin B sulfate is used to treat infections of the urinary tract, meninges and bloodstream caused by susceptible strains of Pseudomonas aeruginosa.

The drug was developed in partnership with Strides Arcolab. Under the collaboration, Strides develops and supplies injectable products that Sagent will market in the United States.

ALLEGAN, Mich. — Perrigo on Wednesday announced that its closing date to complete the acquisition of Paddock Labs — a generic pharmaceutical and specialty over-the-counter products manufacturer — has been delayed by an extended Federal Trade Commission review.

WASHINGTON — The Federal Trade Commission announced on Wednesday that it has reached a settlement with Beiersdorf, the maker of Nivea, regarding advertising claims of its Nivea My Silhouette! skin cream.

The FTC administrative complaint charged Beiersdorf with falsely claiming that by regularly applying Nivea My Silhouette! cream to the skin, consumers could slim down. According to the complaint, Beiersdorf marketed the skin cream in nationwide television ads and through sponsored search results on Google. As part of the settlement, Beiersdorf has agreed to pay $900,000.