EMEA Approves Three More Products

The European Medicines Evaluation Agency has issued marketing authorizations for three new products, namely Eli Lilly's Humalog (insulin lispro), Organon's Puregon (follitropin beta) and Bristol-Myers Squibb's Zerit (stavudine), paving the way for their roll-out across the European Union.

Humalog, approved on April 30, is approved "for the treatment of patients with diabetes mellitus who require insulin for maintenance of normal glucose homeostasis." It is also approved for the initial stabilization of diabetes mellitus. The drug was first launched in Switzerland earlier this year (Marketletter February 19).

Puregon, approved on May 3, is approved "for the treatment of infertility in women who either have not responded to treatment with another ovulation stimulant (clomiphene citrate) or who are undergoing treatment for assisted reproduction techniques."