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P&T August 2015


They Want the Agency to Drop Its Safety-Label Plan and Adopt Their Alternative

Fear of lawsuits and customer confusion have greeted a Food and Drug Administration plan to let generic drug companies change labels quickly, without prior agency approval, when they learn of adverse effects once the generic reaches the market.

Part 1: Disease Entity, Risk Factors, Pathophysiology, Clinical Presentation, and Diagnosis

This article—the first of a five-part series—discusses possible causes, symptoms, diagnosis, and goals for treatment of Parkinson’s disease. Identifying diseases that have similar presentations is an important component of the diagnostic process.

Women with hormone receptor–positive, human epidermal growth factor receptor 2− negative breast cancer—the most common subtype—have new options as palbociclib and similar drugs debut. This article outlines the rationale and evidence for their use.

After killing more than 11,000 people in West Africa, the largest known outbreak of the deadly Ebola virus has largely subsided—but development of effective antiviral countermeasures remains a concern. Several experimental products show promise.

Pipeline Plus

Robust drug-development programs targeting the second most common male cancer (after skin cancer) will help increase U.S. market sales to $3.7 billion by 2023.


Medication Errors

A culture of respect is vital to providing health care safely.

Prescription: Washington

CMS Medicaid plan ignores major drug-access issues.

FDA approvals, drug indications, and updates

Eluxadoline (Viberzi) for irritable bowel syndrome with diarrhea; tiotropium bromide/olodaterol inhalation spray (Stiolto Respimat) for chronic obstructive pulmonary disease; and sirolimus (Rapamune) for lymphangioleiomyomatosis

Drug Forecast

Apremilast (Otezla): A new oral treatment for adults with psoriasis and psoriatic arthritis

Meeting Highlights

We review key research findings on renal cell carcinoma, prostate cancer, melanoma, myelofibrosis, multiple myeloma, and chronic lymphocytic leukemia.