Regulatory and Washington

PARSIPPANY, N.J. — The Food and Drug Administration has approved a drug for opioid dependence made by Actavis, the company said.

Actavis announced the approval of buprenorphine hydrochloride and naloxone hydrochloride dehydrate sub-lingual tablets in the 2 mg/0.5 mg and 8 mg/2 mg strengths.

The drug is a generic version of Reckitt Benckiser's Suboxone, which had sales of about $625 million in 2012, according to IMS Health.

WASHINGTON — U.S. Rep. Erik Paulsen, R-Minn., and Sen. Mike Johanns, R-Neb., last week introduced the Family Health Care Flexibility Act, repealing restrictions placed on health savings accounts and flexible spending accounts in the President’s healthcare law. A provision in the Patient Protection and Affordable Care Act, already in effect today, prohibits HSA and FSA participants from using their account dollars to purchase over the counter medicines without a prescription.  

NEW YORK — Three bills introduced in California's state legislature earlier this month would recognize pharmacists as healthcare providers.

The bills, introduced by state Senate Health Committee chairman Ed Hernandez, would allow pharmacists, nurse practitioners and optometrists to practice the full extent of their education and training.

ATLANTA — The percentage of people who are at risk of developing Type 2 diabetes and aware of it has risen slightly over the past few years, but remains low, according to a report by the Centers for Disease Control and Prevention.

RIDGEFIELD, Conn. — Boehringer Ingelheim and Eli Lilly are seeking regulatory approval for an experimental drug to treat Type 2 diabetes, the companies said Monday.

BI and Lilly announced the submission of a regulatory application to the Food and Drug Administration for empagliflozin. The drug belongs to a new drug class known as SGLT2 inhibitors, which work by removing excess glucose through the urine by blocking its reabsorption in the kidneys. The companies are testing the drug in a late-stage clinical trial for which they plan to enroll 14,500 patients.

EAST HANOVER, N.J. — The Food and Drug Administration has approved a treatment for managing a type of bacterial infection in patients with cystic fibrosis.

Swiss drug maker Novartis announced the approval of Tobi Podhaler (tobramycin inhalation powder) for managing cystic fibrosis patients with Pseudomonas aeruginosa, or Pa bacteria, in the lungs.

FRANKFORT, Ky. — Kentucky on Friday became the first state to enact legislation that provides pharmacists with transparency into how health plans determine pharmacy reimbursements for generic drugs, and establishes an appeals process when a dispute arises over those payment levels. 

Specifically, the new law creates a set of standards with relation to categorizations and formularies for how pharmacy benefit managers craft their MAC lists, requires more frequent updates and streamlines the process for pharmacy reimbursement appeals.

MILPITAS, Calif. — LifeScan on Monday initiated a voluntary recall and replacement for all of its OneTouch VerioIQ blood-glucose meters in the United States, effective immediately.