Recent FDA Approvals - Aug 15 2016

August 15, 2016

Here are some of the most recent drug and device approvals from the Food and Drug Administration:

  • Aurobindo Pharma, an India-based company, received final approval for Linezolid, which is an injectabile anti-infective used to treat gram-positive infections. It is the bio-equivelant to Pharmacia/Upjohn's Zyvox injection, and has an estimated market size of $87 million for the year ending June 2016. 
  • Sun Pharma, another Indian company, has received final FDA approval to market its Metformin Hydrochloride tablets, a generic form of the diabetes drug Glumetza (Santarus). The estimated annual US market for the tablets is $1.2 billion.
  • Merck's monoclonal antibody, Keytruda, picked up another FDA approval, this one for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Keytruda already has FDA approvals for melanoma and lung cancer.
  • Med device company Boston Scientific received approval for its Emblem MRI S-ICD, which will improve upon previous generations of the defibrillator (including allowance for magentic resonance imaging), and which will also be available by software update to patients with previous versions. The device has already been launched in Europe in June.
  • Heron Therapeutics' Sustol was also approved, which is an extended-release injection for chemotherapy-induced nausea and vomiting. The approval was a long time coming, and was originally expected in January.

Sources: The Street, Businesswire, FDA.gov, Pharma Times, Becker Hospital Review, Punja Tribune, Hindu Business Line

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