Most Read Articles
Roshini Claire Anthony, 04 Apr 2019

In addition to an intensive weight loss programme, the use of continuous positive airway pressure (CPAP) could improve absolute weight loss in individuals with obesity and obstructive sleep apnoea (OSA), according to a study presented at ENDO 2019.

2 days ago
The ketogenic and Modified Atkin’s diets are effective treatments for children with refractory epilepsy of genetic aetiology, a new study suggests.
12 Apr 2019
Long-acting beta2-agonist (LABA) plus long-acting muscarinic antagonist (LAMA) combinations compare with inhalers containing both LABA and corticosteroid (LABA-ICS) in terms of reducing chronic obstructive pulmonary disease (COPD) exacerbations, although the LAMA-LABA combination is more favourable as it is associated with fewer episodes of severe pneumonia, according to a study.
3 days ago
Extremely premature neonates who have been exposed to pre-eclampsia in utero are at high risk of developing severe respiratory distress syndrome and severe bronchopulmonary dysplasia, according to a study.

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

01 Jun 2016
New drug applications approved by US FDA as of 16 - 31 May 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.

TECENTRIQ
  • Active Ingredient(s): Atezolizumab
  • Strength: 1200MG/20ML
  • Dosage Form: Injectable; injection
  • Company: Genentech Inc
  • Approval Date: May 18, 2016
  • Chemical Type: Not available
  • Indication(s): Indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:
    • Have disease progression during or following platinum-containing chemotherapy
    • Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
  • Approved Label: 05/18/2016 (PDF)

PROBUPHINE
  • Active Ingredient(s): Buprenorphine hydrochloride
  • Strength: 80MG
  • Dosage Form: Implant;implantation
  • Company: Tita Pharms
  • Approval Date: May 26, 2016
  • Chemical Type: Not available
  • Indication(s): Indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a transmucosal buprenorphine-containing product (i.e., doses of no more than 8 mg per day of Subutex or Suboxone sublingual tablet or generic equivalent)
  • Approved Label: 05/26/2016 (PDF)

JENTADUETO XR
  • Active Ingredient(s): Linagliptin; Metformin hydrochloride
  • Strength: 5MG; 2000MG
  • Dosage Form: Extended release oral tablet
  • Company: Boehringer Ingelheim
  • Approval Date: May 27, 2016
  • Chemical Type:  4  New combination
  • Indication(s): Not available
  • Approved Label: Not available

AXUMIN
  • Active Ingredient(s): Fluciclovine (18F)
  • Strength: 335-8200 MBq/mL (9-221 mCi/mL)
  • Dosage Form: Injectable;injection
  • Company: Blue Earth Diagnostics LTD
  • Approval Date: May 27, 2016
  • Chemical Type: 1  New molecular entity (NME)
  • Indication(s): Indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.
  • Approved Label: 05/27/2016 (PDF)

ZINBRYTA
  • Active Ingredient(s): Daclizumab
  • Strength: 150MG/ML
  • Dosage Form: Injectable; injection
  • Company: Biogen
  • Approval Date: May 27, 2016
  • Chemical Type: 1  New molecular entity (NME)
  • Indication(s): Indicated for the treatment of adult patients with relapsing forms of multiple sclerosis
  • Approved Label: Not available
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Most Read Articles
Roshini Claire Anthony, 04 Apr 2019

In addition to an intensive weight loss programme, the use of continuous positive airway pressure (CPAP) could improve absolute weight loss in individuals with obesity and obstructive sleep apnoea (OSA), according to a study presented at ENDO 2019.

2 days ago
The ketogenic and Modified Atkin’s diets are effective treatments for children with refractory epilepsy of genetic aetiology, a new study suggests.
12 Apr 2019
Long-acting beta2-agonist (LABA) plus long-acting muscarinic antagonist (LAMA) combinations compare with inhalers containing both LABA and corticosteroid (LABA-ICS) in terms of reducing chronic obstructive pulmonary disease (COPD) exacerbations, although the LAMA-LABA combination is more favourable as it is associated with fewer episodes of severe pneumonia, according to a study.
3 days ago
Extremely premature neonates who have been exposed to pre-eclampsia in utero are at high risk of developing severe respiratory distress syndrome and severe bronchopulmonary dysplasia, according to a study.