Schering-Plough submitted a NDA for Zegerid (omeprazole/sodium bicarbonate), in the dosage strength of 20 mg, as a branded over-the-counter (OTC) product to treat frequent heartburn. The NDA was submitted under the terms of a license agreement with Santarus, of San Diego, which was signed in October 2006 for the exclusive US/Canadian rights to market OTC Zegerid proton pump inhibitor (PPI) products using Santarus' technology.
The FDA has approved Auriga Laboratories' Liquadd (dextroamphetamine sulfate), indicated for the treatment of attention deficit disorder with hyperactivity (ADHD). Liquadd will be launched during the second-quarter of 2008. The ADHD market is valued at over $3.5 billion dollars, with approximately 35 million prescriptions written annually.
Spectrum Pharmaceuticals said it received FDA marketing approval for Levoleucovorin for Injection, indicated after high-dose methotrexate therapy in patients with osteosarcoma, and to diminish the toxicity and counteract the effects of impaired methotrexate elimination or inadvertent overdose of folic acid antagonists. Spectrum expects its commercial launch of the treatment by June 2008.