Author: PharmaTimes

The US Food and Drug Administration has given the green light to two new pain drugs – Elan’s Prialt (ziconotide) and Pfizer’s Lyrica (pregabalin) – both of which are expected to be big earners for the companies concerned.

US firm, SuperGen, saw 16% wiped off its share price yesterday after revealing that it had withdrawn the US filing for its pancreatic cancer agent, Orathecin (rubitecan), after the US Food and Drug Administration indicated that the current data package would not be sufficient to win approval at this time.

Eli Lilly has defended itself in the face of claims from the British Medical Journal that the US Food and Drug Administration is to review classified documents that disappeared during a controversial lawsuit over ten years ago linking its Prozac (fluoxetine) antidepressant with suidical attempts and violence, saying that it was not aware of the documents.

GlaxoSmithKline says that the US Food and Drug Administration has given the green light an expanded label for its anti-cancer therapy, Bexxar (tositumomab and I131), to include patients with relapsed or refractory low-grade non-Hodgkin’s lymphoma, including those that have failed on an alternative treatment.

Merck & Co’s share price took another knocking in New York yesterday after US Food and Drug Administration scientist, Dr David Graham, said he was significantly upping his estimates on the number of patients that were harmed as a result of taking the company’s now withdrawn painkiller, Vioxx (rofecoxib) [[01/10/04a]].