Elan Corporation has received "tentative approval" from the US Food and Drug Administration to manufacture and market Nifedipine Extended Release tablets used in the treatment of hypertension, according to the group. It said it will be entitled to 180 days of marketing exclusivity.
Elan noted that introduction of the product would depend on the settlement of legal and patent issues. In March, Elan won a summary judgment against Bayer's allegation that Elan's proposed product would infringe a US patent. Bayer has filed an appeal.