Japanese regulator gives nod to three new drugs

Japan's First Committee on Drugs of the Council on Pharmaceuticals and Food Sanitation has recommended the approval of three new active ingredients including eplerenone, an antihypertensive agent, topiramate, an anti-eplilepsy drug, and rocuronium bromide, a muscle relaxant. The Committee will recommend these approvals to the Subcommittee on Pharmaceutical Affairs in the near future.

Eplerenone, a selective aldosterone receptor antagonist from world drug giant Pfizer, has been approved in the USA under the brand name of Inspra. Topiramate, which will be imported and manufactured by Kyowa Hakko Kogyo, is marketed by Johnson & Johnson unit Ortho-McNeil as Topamax in the USA. The Committee recommends that the drug should be combined with other anti-epileptic agents for patients with partial seizure when other anti-epileptic drugs are not fully effective. Rocuronium, which will be imported by Nippon Organon, is a treatment of muscle relaxation upon anesthesia and insert of tracheal tube. The drug is marketed as Esmeron/Zemuron by Dutch drugmaker Organon.