Regulatory and Washington

STAMFORD, Conn. — The Food and Drug Administration has approved a new dosage strength for a chronic pain patch made by Purdue Pharma, the drug maker said Tuesday.

Purdue announced the approval of the 15-microgram-per-hour strength of Butrans (buprenorphine). The drug is used to treat moderate to severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The new strength is in addition to the 5-microgram, 10-microgram and 20-microgram strengths already on the market, and it will be launched next month.

FLORHAM PARK, N.J. — A decision by the Department of Health and Human Services to resolve conflicts that arose when it issued regulations under a law that establishes privacy rules for health information technology has drawn applause from a specialty pharmacy organization.

SILVER SPRING, Md. — The Food and Drug Administration will not enforce regulatory requirements for most mobile medical apps because they "post minimal risk to consumers," the agency said Monday.

The FDA announced the issuance of guidance on the apps, saying it would adopt a "tailored policy" toward regulation, focusing its regulatory oversight on those apps that present greater risk if they do not work as intended.

ALLEGAN, Mich. — The Food and Drug Administration has approved a drug made by Perrigo Co. for treating heart disease, the company said Monday.

The FDA approved Perrigo's nitroglycerin lingual spray in the 400-mcg-per-spray strength. The drug is used to relieve attacks of or prevent angina pectoris due to coronary artery disease.

LONDON — A Food and Drug Administration panel has recommended that the agency approve an experimental drug for chronic obstructive pulmonary disease made by GlaxoSmithKline and Theravance, the two companies said.

The FDA Pulmonary-Allergy Drugs Advisory Committee voted 9-4 to recommend Breo Ellipta as a long-term maintenance treatment for airflow obstruction in patients with COPD and for reduction of COPD exacerbations in patients with a history of them. The drug is a once-daily inhaler that combines fluticasone furoate and vilanterol.

WASHINGTON — Food and Drug Administration commissioner Margaret Hamburg faced strong criticism Tuesday in a hearing before the House Committee on Energy and Commerce to investigate the nationwide outbreak of fungal meningitis linked to a Massachusetts compounding pharmacy, but she conceded the agency could have done more.

MOUNTAIN VIEW, Calif. — The Food and Drug Administration has approved a modification to a program added to the labeling of an obesity drug to ensure patient safety.

Vivus announced that the FDA had approved changes to the risk evaluation and mitigatin strategy for Qsymia (phentermine and topiramate) extended-release capsules. The amendment to the REMS allows the drug to be dispensed through certified retail pharmacies in addition to the existing network of mail-order pharmacies.

SILVER SPRING, Md. — The Food and Drug Administration will not approve generic versions of Purdue Pharma's painkiller OxyContin based on earlier versions of the drug that did not include features to thwart abuse, the agency said Tuesday.

The FDA announced that it approved updated labeling for reformulated OxyContin (oxycodone) extended-release tablets indicating that it has physical and chemical properties designed to deter drug abusers from crushing or dissolving the pills in order to inject or snort them.