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FDA announced Wednesday that OTC oral health products containing benzocaine for the temporary relief of sore gums due to teething in infants and children should no longer be marketed. The agency, warning that the products pose a serious risk to infants and children, is asking companies to stop selling these products for such use.
Congress on Tuesday gave final approval to legislation that would allow patients with serious illnesses to try unproven experimental treatments, sending the measure to President Trump for his expected signature into law. The House passed the same "right-to-try" bill that was approved in August by unanimous consent in the Senate.
Patients in the clinic had a 3.2-point decrease in A1C at 6 months
FDA approved on Monday avatrombopag (Doptelet—AkaRx) tablets for the treatment of thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure.
JAPhA study: Millions of additional vaccinations are given each year because of ready access at pharmacies
Many ALS patients cannot afford the $145,000 price of the drug edavarone (Radicava—Mitsubishi Tanabe) without insurance, but some insurance provider have denied access to the drug, even though it was approved by FDA last fall for treatment of the disease.
FDA Commissioner Scott Gottlieb discusses steps the agency is taking to address the tactics of some drug manufacturers to forestall expected generic entry. A generic drug developer generally needs 1,500 to 5,000 units of the brand drug to perform what are often relatively straightforward studies for FDA approval.
Aim is to improve safe and effective medications to patients worldwide
FDA approved on Wednesday lofexidine hydrochloride (Lucemyra—US WorldMeds) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults.
While the annual conference focuses on opioid abuse, more programming on appropriate pain management was included this year