January 1 marks the beginning of phased-in implementation of the FDA’s tracking and pedigree regulations for medications, while the first major pharmacy requirements go into effect in July. Beginning this month, drug manufacturers and distributors must provide pharmacies with specific transaction information. They must provide a transaction history and statement that indicates product shipments down to […]
This is the perfect time for doctors and pharmacists to raise awareness about how women can protect themselves from the human papillomavirus, better known as HPV, and cervical cancer. HPV is not only a major cause of cervical cancer – it is also the most commonly diagnosed sexually transmitted disease. An estimated 79 million Americans […]
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.
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 […]
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 […]
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 […]
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 […]
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 […]
