Regulatory and Washington

MADISON, Wis. — The Food and Drug Administration has granted orphan drug designation to a treatment made by Mithridion for a rare neurological disorder, Mithridion said Monday.

ALEXANDRIA, Va. — The National Community Pharmacists Association's long-term care division will receive significant financial support from the Managed Health Care Associates, the NCPA announced Monday.

SAN FRANCISCO — A new bill introduced by a California assemblywoman aims to curb the sale of alcohol to minors by prohibiting sales at self-service checkouts.

Assembly Bill 183, introduced last month by Fiona Ma, D-San Francisco and San Mateo Counties, was passed by the assembly committee. Assemblywoman Ma said that self-service checkouts are susceptible to technological failures, allowing minors to purchase alcohol.

MADISON, Miss. — Cypress Pharmaceuticals has launched a generic version of an eye care drug made by Boehringer Ingelheim and marketed by Allergan, the company said.

Cypress announced the launch of epinastine hydrochloride ophthalmic solution 0.05%, a generic version of Elestat; BI owns the trademark to Elestat and licenses rights to the drug to Allergan. Elestat is used to relieve itching of the eyes resulting from allergic conjunctivitis.

SILVER SPRING, Md. — The Food and Drug Administration is moving forward in the creation of a regulatory approval pathway for follow-on biologics and is requesting input from stakeholders and the public, the agency said Monday.

The FDA plans to use the input it gets to create a user fee program for regulatory approval applications.

In addition to accepting written comments, the agency will consult with scientific and academic experts, healthcare professionals, patient and consumer advocacy groups and companies.

EAST HANOVER, N.J. — The Food and Drug Administration has approved a drug made by Novartis as the first treatment for advanced pancreatic neuroendocrine tumors, Novartis said Thursday.

Novartis announced the approval of Afinitor (everolimus), saying it marked the first approval of a drug for advanced pancreatic NET in nearly 30 years. The drug already is approved for treating cancers of the kidneys and brain.

WASHINGTON — The Council for Responsible Nutrition earlier this week announced the launch of a microsite as part of its joint education campaign with the American Academy of Nurse Practitioners and the American Academy of Nurse Practitioners Foundation.

The new microsite, which will be available via the CRN website, is a hub for resources and information about nurse practitioners in general, as well as their attitudes about and usage of dietary supplements, the association stated.

ATLANTA — The number of people diagnosed with asthma in the United States grew by 4.3 million between 2001 and 2009, according to a new Vital Signs report released earlier this week by the Centers for Disease Control and Prevention.

In 2009, nearly 1-in-12 Americans were diagnosed with asthma. In addition to increased diagnoses, asthma costs grew from about $53 billion in 2002 to about $56 billion in 2007, representing a 6% increase. The explanation for the growth in asthma rates is unknown.