Cor Therapeutics Integrilin
Promotional materials for eptifibatide injection fail "to present any risk information associated with Integrilin's use," FDA tells company in June 25 letter. The agency cited letters to physicians and pharmacists submitted by the company to the agency. Integrilin was approved in May for treatment of patients with acute coronary syndrome and patients undergoing percutaneous coronary intervention ("The Pink Sheet" May 25, p. 11)
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth