The combination therapy in a polypill approach for patients with cardiovascular disease received favor from various FDA officials and agency advisors. The polypill combination therapy concept has been around for a decade, but is not in use at this point. [click to continue…]
The Food and Drug Administration (FDA) recently approved a combination medication, netupitant-palonosetron, to prevent nausea and vomiting in patients receiving chemotherapy. Known as Akynzeo, the medication uses both the neurokinin-1 receptor antagonist netupitant and the serotonin type 3-receptor antagonist palonosetron. Each capsule has three 100-mg netupitant tablets, and one 0.56 mg palonosetron hydrochloride capsule. The medication can be taken with or without food. [click to continue…]
Last month, pharmaceutical manufacturer Hospira announced the voluntary recall of “dozens of product lots,” including a single lot of lidocaine hydrochloride injection, and several lots of injectable products in flexible IV containers.
Hospira recalled lot 40-316-DK of their 30-mL 1% lidocaine hydrochloride injection single dose vials after a report of human hair attached to the stopper one vial was confirmed. The company is investigating the cause of the problem at this time. [click to continue…]
Sanofi and the FDA announced in late August, the approval of a new drug used to treat type 1 Gaucher disease. Eliglustat, or Cerdelga, is approved for the long-term treatment of the condition. Patients with type 1 Gaucher disease have a certain drug-metabolizing enzyme genotype, and this drug is designed to partially inhibit the production of the enzyme that makes glucocerebroside. [click to continue…]
In mid-August, the FDA and Merck announced a new medication approved as an insomnia treatment. Suvorexant is the first drug in its class that’s FDA approved. It is an orexin-receptor antagonist designed to help orexins regulate the sleep-wake cycle.
The FDA has recommended this medication be classified as a Schedule IV controlled substance. The drug will be marketed under the name Belsomra, by the end of the year or early in 2015. Before it can reach the market, the Drug Enforcement Administration, or DEA, must finalize the controlled substance scheduling process. [click to continue…]
The FDA has recently announced the approval of a new drug used to treat relapsing multiple sclerosis. Manufacturer Biogen Idec Inc. announced their peg interferon beta-1a injection, known as Plegridy, received approval as a treatment option for relapsing forms of MS.
By attaching a polyethylene glycol molecule to the interferon beta-1a, it extends the medication’s half life, thus allowing patients to go longer between doses. Their product has a dosing schedule of once every two weeks, while the other two interferon beta-1a products on the market must be administered one to three times a week. [click to continue…]