Content about Regulatory and Washington

WASHINGTON — The North Carolina legislature passed a real-time, stop-sale system, which allows law-abiding citizens to access medicines containing pseudoephedrine, while stopping sales that exceed the legal limit.

The passage was lauded by the Consumer Healthcare Products Association.

SILVER SPRING, Md. — The Food and Drug Administration on Thursday informed the public that continued use of a Type 2 diabetes treatment made by Takeda Pharmaceuticals for more than one year may be associated with an increased risk of bladder cancer.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for preventing organ rejection in kidney transplant patients, the agency said Wednesday.

The FDA approved Bristol-Myers Squibb’s Nulojix (belatacept), for preventing acute rejection in adult patients. The drug is approved for use with other immune system-suppressing drugs, specifically Novartis’ Simulect (basiliximab), Genentech’s CellCept (mycophenolate mofetil) and corticosteroids.

WASHINGTON — There are better ways to reduce expenses for Tricare beneficiaries than to restrict access to community pharmacy. What's more, Congress should adopt alternative cost-saving strategies, including utilizing local pharmacists.

That was a key message in an op-ed co-authored by the National Association of Chain Drug Stores and the National Community Pharmacists Association and published June 13 in The Hill's Congress Blog.

SILVER SPRING, Md. — One month after the observance of Skin Cancer Awareness Month, the Food and Drug Administration announced Tuesday it is taking measures to assure all sunscreen products are safe and effective.

WASHINGTON — One week after the Senate failed to pass an amendment that would have delayed swipe-fee reform for an additional 12 months, the Department of Justice Antitrust Division reportedly is addressing anticompetitive practices related to credit cards.

The agency has submitted a final consent decree in its enforcement action against Visa and MasterCard, according to the Food Marketing Institute.

ABBOTT PARK, Ill. — The Food and Drug Administration has approved a new dosage of a drug made by Abbott for treating cystic fibrosis in infants, the drug maker said Tuesday.

Abbott announced the approval of an infant-specific dose of Creon (pancrelipase) delayed-released capsules to treat exocrine pancreatic insufficiency due to cystic fibrosis.

WASHINGTON — The country’s largest trade group for generic drug companies is concerned that the government’s negotiations on the Trans-Pacific Partnership agreement could hinder competition and access to generic drugs.

The Generic Pharmaceutical Association sent a letter to President Barack Obama Tuesday saying that provisions relating to intellectual property rights for biotech drugs should not be included in the TPP, a proposed regional trade agreement for the Asia-Pacific region.

SILVER SPRING, Md. — The Food and Drug Administration has approved changes to the labels of several drugs made by Merck, the agency said Friday.

Merck’s Label Standardization Project includes the revision of 34 container labels for 16 drugs, all orally administered pills. These include the cardiovascular drugs Cozaar (losartan) and Hyzaar (losartan and hydrochlorothiazide), the diabetes drugs Januvia (sitagliptin) and Janumet (sitagliptin and metformin), the allergy and asthma drug Singulair (montelukast), the HIV drug Isentress (raltegravir) and others.

NEW YORK — A drug for chronic obstructive pulmonary disease made by Forest Labs will be available by the middle of this month, Forest said Thursday.

Daliresp (roflumilast) recently received approval from the Food and Drug Administration as a treatment to reduce the risk of exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

Forest said Daliresp, a daily oral tablet, is the first and only approved drug in its class, known as selective phosphodiesterase-4 inhibitors.

SILVER SPRING, Md. — The Food and Drug Administration is seeking to limit the use of high doses of a drug for high cholesterol due to the risk of a muscle injury known as myopathy.

NEW YORK — The National Advertising Division of the Council of Better Business Bureaus earlier this week recommended that New Nordic US modify or discontinue a wide range of advertising claims for the company’s Mulberry Zuccarin dietary supplement product, including claims made in testimonials.