Regulatory and Washington

PRINCETON, N.J. — The Food and Drug Administration has approved a drug made by Bristol-Myers Squibb for injection under the skin to treat rheumatoid arthritis, Bristol said Friday.

The New York-based drug maker said the approval of Orencia (abatacept) for subcutaneous injection in patients with moderate to severe RA made it the first biotech drug for RA available in self-injectable and intravenous infusion formulations.

SAN FRANCISCO — CytoSport recently reported its receipt of a letter from the San Francisco office of the Food and Drug Administration alerting the company to concerns about its use of the word “milk” in its Muscle Milk trade name and to questions about the language used to describe Muscle Milk to consumers.

PHILADELPHIA — The Food and Drug Administration has approved a generic version of a short-term adjunct treatment for obesity.

Lannett said that the FDA approved its abbreviated new drug application for phentermine resin extended-release capsules in the 15-mg and 30-mg strengths. The drug, which is equivalent to UCB's Ionamin, will be sold in bariatric clinics.

WASHINGTON — New guidelines that will ensure women receive preventive health services at no additional cost were announced Monday by the Department of Health and Human Services.

Developed by the independent Institute of Medicine, the new guidelines require new health insurance plans to cover women’s preventive services, such as well-woman visits, breast-feeding support, domestic violence screening and contraception without charging a co-payment, co-insurance or a deductible.

BANGALORE, India — The Food and Drug Administration has approved a generic drug for diabetes made by Indian generic drug maker Strides Arcolab.

The FDA approved acarbose tablets in the 25-mg, 50-mg and 100-mg strengths. The drug is a niche drug used to treat Type 2 diabetes, Strides said.

Acarbose tablets have sales of about $21 million, according to IMS Health.

JERUSALEM — Teva Pharmaceuticals has launched an authorized generic version of a contraceptive made by Duramed Pharmaceuticals, Teva said.

Teva announced the launch of Camrese, an authorized generic of Duramed’s Seasonique (levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets).

The launch of Teva’s authorized generic follows the launch of Watson Pharmaceuticals’ generic version of the drug, which it is marketing under the name Amethia.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has asked Eisai to redo its regulatory application for a drug to treat epilepsy, Eisai said Friday.

The drug maker said the FDA issued a refusal to file letter in response to its application for perampanel, designed to treat partial-onset seizures in patients with epilepsy. In the letter, the FDA requested reformatting and reanalyses of some datasets, though Eisai said new studies probably were unnecessary.

WASHINGTON — Sens. Ben Cardin, D-Md., and Mike Enzi, R-Wyo., last week introduced the Medical Flexible Spending Account Improvement Act (S. 1404), a bill that would allow consumers to pay taxes on and withdraw any remaining funds in their employer-sponsored flexible spending accounts.

Current rules require that any leftover balance in an FSA must be forfeited to the employer at the end of the plan year, oftentimes identified as the "use it or lose it" provision.