Pharmaceutical Approval Update


Aminolevulinic Acid Hydrochloride (Gleolan)

Manufacturer: NX Development Corp., Lexington, Kentucky

Date of Approval: June 6, 2017

Indication: Gleolan is indicated in patients with glioma (suspected World Health Organization [WHO] grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery.

Delafloxacin (Baxdela)

Manufacturer: Melinta Therapeutics, Lincolnshire, Illinois

Date of Approval: June 19, 2017

Indication: Delafloxacin is indicated in adult patients for treating acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible isolates of the following:

  • Gram-positive organisms: Staphylococcus aureus (including methicillin-resistant and methicillin-susceptible isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis,Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus,Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, andEnterococcus faecalis
  • Gram-negative organisms: Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, andPseudomonas aeruginosa


Glecaprevir/Pibrentasvir (Mavyret)

Manufacturer: AbbVie, Inc., North Chicago, Illinois

Date of Approval: August 3, 2017

Indication: Mavyret, a fixed-dose combination of glecaprevir (a hepatitis C virus [HCV] NS3/4A protease inhibitor) and pibrentasvir (an HCV NS5A inhibitor), is indicated for treating patients with chronic HCV infection of genotypes (GT) 1–6 without cirrhosis and with compensated cirrhosis (Child–Pugh A). It is also indicated for the treatment of adults with HCV GT1 infection who were previously treated with a regimen containing an NS5A inhibitor or an NS3/4A protease inhibitor, but not both.

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