FDA Approvals

First US cholera vaccine availableFDA approved the first US vaccine for cholera, Vaxchora, made by PaxVax Bermuda Ltd. in Hamilton, Bermuda. Vaxchora is the only single-dose vaccine for cholera currently licensed anywhere in the world.
Teva halts migraine patch sales over burnsTeva Pharmaceuticals is temporarily suspending sales and distribution of its sumatriptan iontophoretic transdermal system (Zecuity) patch for migraines, after FDA said it is investigating the risk of serious burns with the use of the patch.
New hypertension drug gets FDA approvalThe first and only fixed-dose combination of a beta blocker beta blocker (BB) and angiotensin II receptor blocker (ARB) for hypertension will be available in the US in the second half of the year. FDA approved nebivolol and valsartan (Byvalson, Allergan) 5 mg/80 mg tablets in early June.
FDA approves Zinbryta to treat multiple sclerosisFDA recently approved daclizumab (Zinbryta, Biogen and AbbVie), a once-monthly, self-administered, subcutaneous treatment for relapsing forms of multiple sclerosis (RMS).
First 4-strain flu vaccine availableFDA recently approved the first 4-strain, cell culture-derived, inactivated seasonal flu vaccine available in the United States. Flucelvax Quadrivalent influenza vaccine (Seqirus) helps protect against the 2 influenza A viruses and two B viruses recommended by the World Health Organization (WHO) and the FDA for the current influenza season.
New diabetes drug enters competitive marketIn a major new entry in the diabetes market, FDA just approved linagliptin and metformin hydrochloride extended-release tablets (Jentadueto XR, Boehringer Ingelheim and Eli Lilly and Company) to treat type 2 diabetes.
Why new bladder cancer drug is novelFDA recently granted accelerated approval for atezolizumab (Tecentriq, Genentech), the first drug for bladder cancer that utilizes the body’s immune system. The drug will be available by early June.
New treatment for kidney cancer gets OKFDA has approved lenvatinib (Lenvima, Eisai Inc.) in combination with everolimus for the treatment of advanced renal cell carcinoma.
Opdivo snags two new cancer approvalsNivolumab (Opdivo, Bristol-Myers Squibb) received two new approvals from FDA to treat two different cancers.
First drug approved for hallucinations in Parkinson’sFDA approved the first drug to hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease.