Almost one third of the new therapeutics approved by the FDA between 2001 and 2010 were affected by a postmarket safety event.
Clinicians should prescribe generic medications over brand-name drugs when they can because the generics are less expensive and molecularly identical.
A new survey indicates that pharmaceutical representatives have restricted access to over half of clinicians.
Sofosbuvir is indicated for use with other medications as part of an antiviral treatment regimen for chronic hepatitis C infection.
Fycompa is indicated to treat partial-onset seizures in patients aged 12 years and older.
Pharmaceutical giant first drug maker to adopt such a policy and may encourage others to follow suit.
The FDA is looking into the cause of death of two patients who died several days after receiving injections of Zyprexa Relprevv.
High discontinuation rates with traditional second-line therapies suggest more overactive bladder treatment options are needed.
As the patent on the original formulation expires, the FDA introduces new label and blocks NDAs for generic versions that lack abuse-deterrent properties.
Clinicians must carefully question our patients about the source of their prescription drugs to make sure they are obtaining these products from legitimate sources.
Greater cooperation needed between federal and state health inspectors to oversee compounding pharmacies, which fall into a regulatory gray zone between various state and federal laws.
Drug manufacturer Qualitest has issued a nationwide voluntary recall of one lot of hydrocodone bitartrate and acetaminophen 10mg/500mg tablets due to potentially over-sized tablets.
The FDA has approved bosutinib (Bosulif, Pfizer) for patients with chronic, accelerated or blast phase Philadelphia chromosome positive CML, who are resistant to or who cannot tolerate other therapies.
The FDA has approved tbo-filgrastim to treat neutropenia in patients with nonmyeloid malignancies, who receive myelosuppressive chemotherapy.
The first pediatric form of the cancer drug everolimus has been sanctioned to treat rare brain tumors in children aged 1 year and older.
Linzess sanctioned for constipation that does not respond to conventional treatment.
FDA warns that counterfeit drug may be ineffective and potentially harmful.
The FDA has added new contraindications to fingolimod's label, and more detailed recommendations for monitoring patients after dosing.
Prefilled glass cartridges of hydromorphone HCI injection 1 mg/mL manufactured by Hospira may contain more than the labeled 1 mL fill volume.
American Regent has issued a nationwide voluntary recall of epinephrine injection, 1:1000, 1mL ampules after concerns that visible particulates in some ampules could cause adverse events if administered intravenously.
The FDA has approved the oral contraceptive, Natazia, to treat women with heavy menstrual bleeding that is not caused by a diagnosed condition of the uterus.
Surfaxin (lucinactant) is indicated for the prevention of respiratory distress syndrome, a breathing disorder that affects premature infants.
Drug interactions between statins and certain protease inhibitors for HIV or hepatitis C can increase the risk for myopathy, including rhabdomyolysis.
Sleeping pill use was associated with a three- to five-fold higher mortality risk compared to nonuse, even among patients taking relatively few pills a year.
Glenmark Generics Inc. has issued a voluntary nationwide recall of seven lots of the oral contraceptives norgestimate and ethinyl estradiol, after consumers reported that the tablets in some packages were in reverse order.
American Regent has issued a nationwide voluntary recall of Phenylephrine HCl Injection, USP, 1% (10mg/mL), 5mL vials.
McNeil Consumer Healthcare is voluntarily recalling seven lots of Infants' Tylenol Oral Suspension, 1oz Grape, distributed nationwide in the U.S.
The FDA is warning health care professionals about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the United States.
Taking boceprevir with ritonavir-boosted HIV protease inhibitors together reduces the effectiveness of both therapies, the FDA announced.
Merck announced that the FDA has approved Janumet XR (sitagliptin/metformin HCl extended-release tablets) for the treatment of type 2 diabetes.