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.
4 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 (1 - 15 September 2018)

15 Sep 2018
New drug applications approved by US FDA as of 1 - 15 September 2018 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.

TIGLUTIK
  • Active Ingredient(s): Riluzole
  • Strength: 50MG/ML
  • Dosage Form(s)/Route(s): Suspension; Oral
  • Company: Italfarmaco SpA
  • Approval Date: 09 Sep 2018
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of amyotrophic lateral sclerosis (ALS)
  • Approved Label: 09 Sep 2018 (PDF)
CASSIPA
  • Active Ingredient(s): Buprenorphine; Naloxone
  • Strength: 16MG; 4MG
  • Dosage Form(s)/Route(s): Film; Buccal, Sublingual
  • Company: Teva Pharms USA Inc
  • Approval Date: 07 Sep 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the maintenance treatment of opioid dependence
  • Approved Label: 07 Sep 2018 (PDF)
XELPROS
  • Active Ingredient(s): Lantanoprost
  • Strength: 0.005%
  • Dosage Form(s)/Route(s): Emulsion; Ophthalmic
  • Company: Sun Pharma Global
  • Approval Date: 12 Sep 2018
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for reduction of elevated intraocular pressure in patients with open-angle glaucoma, or ocular hypertension
  • Approved Label: 12 Sep 2018 (PDF)
LUMOXITI
  • Active Ingredient(s): Moxetumomab pasudotox-tdfk
  • Strength: 1MG/VIAL
  • Dosage Form(s)/Route(s): Injectable; Injection
  • Company: AstraZeneca AB
  • Approval Date: 13 Sep 2018
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA)
  • Approved Label: 13 Sep 2018 (PDF)
SEIZALAM
  • Active Ingredient(s): Midazolam
  • Strength: 5MG/ML
  • Dosage Form(s)/Route(s): Injectable; Injection
  • Company: Meridian Medical Techn.
  • Approval Date: 14 Sep 2018
  • Submission Classification: Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated
  • Indication(s): Not available
  • Approved Label: Not available
AJOVY
  • Active Ingredient(s): Fremanezumab-VFRM
  • Strength: 150MG/ML
  • Dosage Form(s)/Route(s): Injectable; Injection
  • Company: Teva Pharms USA
  • Approval Date: 14 Sep 2018
  • Submission Classification: Not available
  • Indication(s): Indicated for the preventive treatment of migraine in adults
  • Approved Label: 14 Sep 2018 (PDF)
Editor's Recommendations
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.
4 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.