Regulatory and Washington

NEW YORK — Officials in Rhode Island may set up a registry that would allow doctors and pharmacists to track patients who have problems with drug abuse, according to published reports.

The Associated Press reported that the proposed registry would track prescriptions for drugs that are controlled substance and allow healthcare professionals to track their usage, similar to a monitoring program set up in New York this year. A task force that includes state lawmakers, health officials and healthcare professionals met Monday to look at the idea.

NOIDA, India — The Food and Drug Administration has approved a generic version of a drug for schizophrenia and bipolar disorder made by Jubilant Life Sciences, the Indian drug maker said.

Jubilant announced the approval of quetiapine fumarate tablets in the 25-mg strength. The drug is a generic version of AstraZeneca's Seroquel.

Various versions of the drug have annual sales of about $59 million, according to IMS Health.

GOODLETTSVILLE, Tenn. — Dollar General before the Thanksgiving holiday refuted a recent U.S. PIRG Education Fund study — Trouble in Toyland 2013 — which suggested a toy jewelry ring set that tested twice the legal limit for lead was sold at Dollar General stores. 

"This product is not currently, nor has ever been, sold in Dollar General stores," the dollar store operator said. 

NEW YORK — Deloitte has issued a report showing that employers view the health care system as wasteful and expensive, and that the keys for improving the system are increased transparency around pricing and performance — both tenets of outcomes-based medicine. 

JERUSALEM — The Food and Drug Administration has designated a drug made by Teva Pharmaceutical Industries as an orphan drug, the company said.

Teva said the drug, Treanda (bendamustine hydrochloride), received the designation for indolent B-cell non-Hodgkins lymphoma through October 2015 that has progressed during or within six months of treatment with a regimen containing Rituxan (rituximab), marketed by Genentech and Biogen Idec. The FDA gives orphan drug designation to treatments for diseases affecting fewer than 200,000 people in the United States.

SILVER SPRING, Md. — A new study is helping to provide a better understanding of vaccines for whooping cough, the Food and Drug Administration announced Wednesday. Based on an animal model, the study shows that acellular pertussis vaccines licensed by the FDA are effective in preventing the disease among those vaccinated, but suggests that they may not prevent infection from the bacteria that causes whooping cough in those vaccinated or its spread to other people, including those who may not be vaccinated.

NEW YORK — The National Advertising Division has referred advertising claims made by Maxam Nutraceuticals for its PCA dietary supplement to the Federal Trade Commission for further review, after the company declined to participate in a review of its claims.

The Council for Responsible Nutrition challenged claims made by Maxam in television and Internet advertising, including:

STAMFORD, Conn. — The Food and Drug Administration has accepted Purdue Pharma's regulatory approval application for a new opioid drug, Purdue said Tuesday.

The drug maker announced the FDA's acceptance of its application for Targiniq (oxycodone hydrochloride; naloxone hydrochloride) controlled-release tablets. The drug combines oxycodone with the opioid agonist nalxone.