Content about Regulatory and Washington

JERUSALEM — The Food and Drug Administration has approved a new contraceptive therapy made by Teva Pharmaceutical Industries, Teva said Monday.

The drug maker announced the approval of Quartette (levonorgestrel, ethinyl estradiol and ethinyl estradiol) tablets. Teva said the drug represented the "next generation" of extended-regimen oral contraceptives and was designed to minimize breakthrough bleeding between scheduled periods.

AURORA, Colo. — A Colorado-based firm will install solar power systems at 22 Walgreens stores in 14 cities in the state over the next few months, under a partnership between the two companies.

Walgreens announced Monday an expansion of its relationship with SolarCity, saying the new power systems would reduce more than 47.5 million pounds of carbon dioxide emissions over the next two decades.

ATLANTA — Coca-Cola has filed a patent application with the U.S. Patent and Trademark Office for a new sugar-free beverage with added fiber, according to a report from the Atlanta Business Chronicle.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Johnson & Johnson for treating Type 2 diabetes, the agency said.

The FDA announced the approval of J&J subsidiary Janssen Pharmaceuticals' Invokana (canagliflozin) tablets, designed for use with diet and exercise to improve blood-sugar control in adults with the disease.

WASHINGTON — A new Medicare Chronic Conditions Dashboard announced today by Marilyn Tavenner, acting administrator of the Centers for Medicare and Medicaid Services (CMS), furthers the Patient Protection and Affordable Care Act’s goals for health promotion and the prevention and management of multiple chronic conditions.

WASHINGTON — The head of Ahold USA's Giant-Landover banner has pledged the supermarket chain's support for the Department of Defense's Employer Support of the Guard and Reserve.

Giant-Landover, officially Giant Food of Landover, Md., said president Anthony Hucker signed a statement of support for National Guard and reserve employees at the Brentwood Giant Food in Washington, accompanied by ESGR District of Columbia chairman George Alexander. Established in 1972, the ESGR develops and maintains employer support for the Guard and Reserve service.

NEW YORK — The Department of Health and Human Services issued a new rule that it said was necessary to protect the security of health information stored online.

As required by the Health Information Technology for Economic and Clinical Health Act, which was part of the 2009 economic stimulus bill, HHS said it would change patient privacy rules in the Health Insurance Portability and Accountability Act in order to provide for privacy and security protection for information stored in electronic health records.

FRANKLIN LAKES, N.J. — The Food and Drug Administration has approved a drug administered through a new line of injection devices made by BD, the company said Wednesday.

BD announced the approval of diphenhydramine hydrochloride injection, an antihistamine, packaged in its recently launched Simplist pre-filled injectables, which are made by subsidiary BD Rx and designed to improve patient care and safety by decreasing the number of steps in the traditional vial and syringe injection sequence and thus reduce the potential risk of medication errors.

MILWAUKIE, Ore. — The American Association of Homeopathic Pharmacists on Wednesday honored Sen. Tom Harkin, D-Iowa, with an award of appreciation for introducing and supporting legislation that safeguards Americans' right to choose complementary health care. Chairman of the Senate Health, Education, Labor and Pensions Committee, Harkin has been a longtime supporter of patient access to homeopathic medicines, AAHP noted. 

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.