FDA is re-examining the safety of a breakthrough Parkinson’s disease drug after reports of hundreds of deaths.
Christine Blank, Contributing Editor
After FDA approved the first epinephrine injection specifically for infants and toddlers last year, the drug is now on the market.
Walmart, CVS Health, and a number of other healthcare organizations are supporting a new multi-million dollar consumer campaign to combat high prescription drug prices.
Late last week, FDA approved a new drug to treat acute myeloid leukemia (AML), the first treatment for Batten disease, and expanded the use of a current drug to treat liver cancer.
A new abuse-deterrent painkiller - oxycodone hydrochloride (RoxyBond, Inspirion Delivery Services) - will be available soon after receiving FDA approval.
In what is expected to produce hefty saving for rheumatoid arthritis patients and the healthcare system, FDA approved the second biosimilar to Remicade (Johnson & Johnson).
FDA said this week that it is restricting the use of codeine and tramadol medicines in children. The drug’s labels will now include a contraindication that codeine should not be used to treat pain or cough, and that tramadol should not be used to treat pain, in children younger than 12 years.
Citing safety concerns, FDA delayed approval of a new blockbuster drug to treat rheumatoid arthritis.
FDA approved supplemental applications for 2 primary hepatitis C medications to be used in children for the first time.
FDA recently approved deutetrabenazine (Austedo, Teva Pharmaceuticals) to treat chorea associated with Huntington’s disease (HD). The medication is only the second product approved to treat HD, and is the first deuterated product approved by FDA.