FDA approves abuse-deterrent OxyContin labeling
As the patent on the original formulation expires, the FDA introduces new label and blocks NDAs for generic versions that lack abuse-deterrent properties.
Pharmaceuticals
Desperation leads patients online for Rx meds
Clinicians must carefully question our patients about the source of their prescription drugs to make sure they are obtaining these products from legitimate sources.
FDA calls for new rules for compounding pharmacies
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.
Qualitest recalls hydrocodone bitartrate and acetaminophen tablets
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.
Bosutinib approved for chronic myelogenous leukemia
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.
New drug approved for chemo-related severe neutropenia
The FDA has approved tbo-filgrastim to treat neutropenia in patients with nonmyeloid malignancies, who receive myelosuppressive chemotherapy.
Pediatric everolimus dose approved to treat rare brain tumor
The first pediatric form of the cancer drug everolimus has been sanctioned to treat rare brain tumors in children aged 1 year and older.
FDA approves Linzess for IBS, chronic constipation
Linzess sanctioned for constipation that does not respond to conventional treatment.
Online Adderall may contain wrong active ingredients
FDA warns that counterfeit drug may be ineffective and potentially harmful.
FDA places restrictions on oral MS drug
The FDA has added new contraindications to fingolimod’s label, and more detailed recommendations for monitoring patients after dosing.
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