Regulatory and Washington

ALEXANDRIA, Va. In a clear message to the newly elected lawmakers that pharmacies can be utilized even more effectively to help reduce healthcare costs and improve healthcare quality, the National Association of Chain Drug Stores sent a pharmacy briefing letter Friday to each of the new lawmakers.

 

INDIANAPOLIS The Food and Drug Administration has approved a new usage for a drug used to treat depression and pain.

Eli Lilly said Thursday that the FDA had approved Cymbalta (duloxetine hydrochloride) for treating chronic musculoskeletal pain. This is the fifth indication for which the agency has approved Cymbalta, after major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain and fibromyalgia, Lilly said.

WASHINGTON Under the Affordable Care Act, the average savings for those enrolled in traditional Medicare is expected to amount to more than $3,500 over the next 10 years — and will be even higher for seniors and people with diabetes who have high drug costs — according to the U.S. Department of Health and Human Services.

 

SILVER SPRING, Md. The Food and Drug Administration has approved a generic treatment made by Lupin Pharmaceuticals for allergies, according to FDA records.

 

The drug is a generic version of Schering-Plough’s Clarinex.

 

 

Clarinex has annual sales of around $229 million, according to IMS Health data reported by several media in India, where Lupin is based.

 

DANBURY, Conn. The Food and Drug Administration has turned down an application for an insulin product made by Biodel, Biodel said.

 

The drug maker announced that it received a complete response letter from the FDA for Linjeta (human insulin [rDNA origin]) for the treatment of Type 1 and Type 2 diabetes.

 

 

SILVER SPRING, Md. The main lobbies for the biotechnology and generic drug industries, and a leading manufacturer of generic drugs, testified Wednesday at a hearing sponsored by the Food and Drug Administration to collect public and industry input on the implementation of the regulatory approval pathway for follow-on biologics included in the healthcare-reform bill.

 

THOUSAND OAKS, Calif. Amgen's SVP research and development, Joe Miletich, urged members of a Food and Drug Administration panel to establish approval standards for biosimilars that ensure patient safety and follow a science-based approach.

“Put patients first and sound policy will follow,” Miletich said. “Amgen believes biosimilars have a meaningful role to play in the healthcare system. However, dissimilar — unlike generic drugs — are not identical to the innovative biological products.” 

ALEXANDRIA, Va. The National Association of Chain Drug Stores is urging federal health officials to adopt a simpler means of communicating drug safety and efficacy information to patients, and to clear the way for an approval pathway for generic versions of biologically engineered drugs.

 

NACDS made its priorities known in a letter Monday to Margaret Hamburg, commissioner of the Food and Drug Administration. The letter came from Kevin Nicholson, the group’s VP government affairs and public policy.