22 MARKET NEWS News from the US FDA

A US FDA advisory committee has unanimously recommended that Knoll's propafenone [Rythmol®] should be approved for the prophylaxis of paroxysmal supraventricular tachycardia and paroxysmal atrial fibrillation and flutter, according to the Pink Sheet [28 Mar]. However, as propafenone has proarrhythmic potential, the committee also recommended that labelling of the new product should include a warning about a possible increased risk of mortality, similar to the labelling of flecainide.

The news was less positive for Otsuka America's vesnarinone [Arkin®], with the advisory committee concluding that a confmnatory efficacy trial in patients with congestive heart failure was needed before approval could be recommended for the new agent.

MGI Pharma has received approval for pilocarpine [Salagen®], a new treatment for radiation-induced chronic dry mouth in patients with cancer of the head and neck. Pilocarpine has orphan drug status for this indication and is the first such drug to be approved. Marketing is expected to begin in early May.

The antiemetic granisetron [Kytril®] has been launched by SrnithKline Beecham at a cost about 7.2% lower than that of Glaxo's ondansetron [Zofran®].

Westwood-Squibb, a division of Bristol-Myers Squibb, has launched the vitamin D3 derivative calcipotriol [Dovonex®] for the treatment of psoriasis [Phannaceutical Business News 22 Mar; p9].

9 Apr 1994 INPHARMA- 0156·2703l94/0932·00022l$1.ocf Adl. Internatlon.1 Limited 1994. All right. reHrVed