Regulatory and Washington

INDIANAPOLIS — The Food and Drug Administration has approved a new treatment for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim, the drug makers said.

The FDA approved Jentadueto (linagliptin and metformin) tablets, designed to be taken twice daily. The approval marks the second since the two companies announced their collaboration to develop diabetes drugs in January 2011; the first drug approved under the Lilly-BI partnership was Tradjenta (linagliptin), approved in May 2011.

SACRAMENTO, Calif. — California state officials tentatively are blocked from moving forward with a 10% Medi-Cal reimbursement rate cut.

The court decision, handed down by Judge Christina Snyder, was applauded by several organizations, including the California Medical Association, the California Dental Association, the National Association of Chain Drug Stores, the California Association of Medical Product Suppliers, the AIDS Healthcare Foundation and the American Medical Response.

WASHINGTON — For every dollar spent on over-the-counter medicines, the U.S. healthcare system realizes a savings of between $6 and $7, or $102 billion all told, the Consumer Healthcare Products Association announced Tuesday with the release of this new study, "The Value of OTC Medicine to the United States."

WASHINGTON — The Natural Products Association last week announced it will host its 15th Annual Natural Products Day to help educate policy-makers on the value of dietary supplements here on March 27.

The day begins with an issue briefing and advocacy training so attendees learn how they can participate in the policy-making process and advocate for their interests. Afterwards, pre-arranged meetings at congressional offices offer the chance to talk to senators, representatives and their staffs about key legislation and regulatory activities.

PHILADELPHIA — The Food and Drug Administration has approved a generic drug for obesity made by Lannett, the drug maker said Tuesday.

Lannett announced the approval of phentermine hydrochloride capsules in the 15-mg strength.

Various versions of the drug had sales of $11 million at average wholesale price in 2011, according to Wolters Kluwer.

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SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Vertex Pharmaceuticals for treating a rare form of cystic fibrosis, the agency said Tuesday.

The FDA announced the approval of Kalydeco (ivacaftor) for treating patients ages 6 years and older with CF who have a mutation called G551D in the cystic fibrosis transmembrane regulator gene.

SAN DIEGO — The Food and Drug Administration has approved a long-acting injected diabetes drug made by Amylin Pharmaceuticals and Alkermes, the two companies said.

The FDA approved Bydureon (exenatide), which the companies called the first once-weekly treatment for Type 2 diabetes. The drug will become available in February.

DEERFIELD, Ill. — Walgreens on Monday announced its acquisition of the prescription files and inventory from 33 Kmart pharmacies in 16 states.

Walgreens will purchase the pharmacy patient files and transfer them to nearby Walgreens pharmacies, the company stated.

Walgreens completed the acquisition of the first pharmacy's prescription files and inventory Jan. 27 in Rice Lake, Wis. Acquisition of the other Kmart prescription files and inventory is subject to certain customary terms and conditions, and is anticipated to happen throughout February.