Most Read Articles
Roshini Claire Anthony, 29 Aug 2018

Teenagers and young adults living with perinatally acquired HIV (PaHIV) have a higher risk of developing malignancies and a higher all-cause mortality rate than their non-HIV-infected peers, according to a study from the UK.

Original New Drug Application Approvals by US FDA (16 - 31 July 2016)

31 Jul 2016
New drug applications approved by US FDA as of 15 - 31 July 2016 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

RELISTOR
  • Active Ingredient(s): Methylnatrexone bromide
  • Strength: 150MG
  • Dosage Form: Oral tablet
  • Company: Salix Pharms
  • Approval Date:  July 19, 2016
  • Chemical Type: 3  New dosage form
  • Indication(s): Indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain
  • Approved Label: 07/19/2016 (PDF)

VIEKIRA XR
  • Active Ingredient(s): Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
  • Strength: 200MG; 8.33MG; 50MG; 33.33MG
  • Dosage Form: Extended-release oral tablet
  • Company: Abbvie
  • Approval Date: July 22, 2016
  • Chemical Type: 3  New dosage form
  • Indication(s): Indicated for the treatment of adult patients with chronic hepatitis C virus (HCV):
    • genotype 1b infection without cirrhosis or with compensated cirrhosis
    • genotype 1a infection without cirrhosis or with compensated cirrhosis for use in combination with ribavirin
  • Approved Label: 07/22/2016 (PDF)

ADLYXIN
  • Active Ingredient(s): Lixisenatide
  • Strength: 0.05MG/ML; 0.1MG/ML
  • Dosage Form: Injectable; injection
  • Company: Sanofi-Aventis US LLC
  • Approval Date: July 27, 2016
  • Chemical Type: 1  New molecular entity (NME)
  • Indication(s): Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
  • Approved Label: 07/27/2016 (PDF)

QBRELIS
  • Active Ingredient(s): Lisinopril
  • Strength: 1MG/ML
  • Dosage Form: Oral solution
  • Company: Silvergate Pharms
  • Approval Date: July 29, 2016
  • Chemical Type: 3  New dosage form
  • Indication(s): Not available
  • Approved Label: Not available
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Most Read Articles
Roshini Claire Anthony, 29 Aug 2018

Teenagers and young adults living with perinatally acquired HIV (PaHIV) have a higher risk of developing malignancies and a higher all-cause mortality rate than their non-HIV-infected peers, according to a study from the UK.