Changes at Andrx
Fort Lauderdale, FL-based drug company Andrx Corporation has said it will pursue fewer early stage brand development opportunities and will increase its utilisation of clinical research organisations (CROs) for its later stage development efforts.
Fort Lauderdale, FL-based drug company Andrx Corporation has said it will pursue fewer early stage brand development opportunities and will increase its utilisation of clinical research organisations (CROs) for its later stage development efforts.
This shift in focus has led in a reduction in personnel employed in the company's clinical operations in New Jersey and Florida, and the promotion of Dr Josephine Cucchiaro and Judith Jaeger, MD to vice president positions, overseeing the reorganised brand business unit's clinical development and safety operations. However, the company's brand sales force will be increased in 2004 to prepare for the expected launch of Cardura XL, following an agreement with Pfizer, which the company anticipates marketing to urologists as well as primary care physicians.
Andrx has also won a temporary restraining order preventing the FDA from granting final approval of Eon Labs' abbreviated new drug application (ANDA) for extended release Bupropion Hydrochloride, 100 mg tablets, which is bioequivalent to Andrx's Wellbutrin SR. Andrx filed its lawsuit believing it was the first-to-file an ANDA for this product, and therefore entitled to the 180-day market exclusivity period provided by law.