The FDA has issued a Public Health Advisory highlighting the risk of sepsis in patients undergoing medical abortion using Danco Laboratories' mifepristone (Mifeprex) and misoprostol in a manner that is not consistent with the approved labeling.
FDA alerts of sepsis risk with mifepristone
Topical anesthetic patch gains approval
Novel sleep medication approved for long-term use
The FDA has approved Takeda Pharmaceuticals' Rozerem (ramelteon) 8-mg tablets for the treatment of insomnia characterized by difficulty with sleep onset. The approval allows physicians to prescribe the drug for long-term use in adults. According to Takeda, ramelteon is the only prescription sleep drug that has not demonstrated evidence of abuse and dependence and, therefore, was not classified as a controlled substance by DEA. Additionally, the company reports ramelteon is the first Rx insomnia drug with a new therapeutic mechanism of action in 35 years. It works by selectively targeting two receptors in the brain's suprachiasmatic nucleus, which regulates a person's 24-hour biological cycle, including the sleep-wake cycle. The drug should be available in pharmacies by late September.
Neuropathic pain product now a scheduled drug
DEA has classified pregabalin (Lyrica, Pfizer) as a Schedule V controlled substance, subject to all the storage and dispensing requirements under that class. The capsule is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia. This DEA final rule was published in the July 28 Federal Register.
TEVA acquires IVAX
In a move that will create the largest generic drug manufacturer, TEVA Pharmaceutical Industries Ltd. signed an agreement to acquire IVAX Corp. The combined company is expected to generate sales of more than $7 billion and will employ about 25,000 people in more than 50 countries. The $7.4 billion deal comes in the wake of Novartis AG's recent acquisition of Eon Labs.
Express Scripts buys specialty pharmacy
Express Scripts has agreed to buy the specialty pharmacy Priority Healthcare for about $1.3 billion. The cash sale is expected to close later this year, subject to stockholder and regulatory approvals. The St. Louis-based PBM will combine Priority Healthcare with the specialty pharmacy CuraScript, which it acquired in January 2004. Express Scripts anticipates annual sales in excess of $3 billion for the combined operation.
Crawford confirmed to head FDA
The Senate confirmed Lester Crawford as FDA commissioner. Crawford had served as acting commissioner for a year following Mark McClellan's move to head CMS, as well as previously serving as deputy FDA commissioner. APhA applauded Crawford's confirmation and noted that having a permanent commissioner is essential for the agency to fulfill its public health role. NACDS had praised him last February as a "noteworthy choice" following his nomination by President Bush.