Most Read Articles
17 Apr 2019
The ketogenic and Modified Atkin’s diets are effective treatments for children with refractory epilepsy of genetic aetiology, a new study suggests.
Pearl Toh, 17 Apr 2019
A contraceptive vaginal system (Annovera) releasing a combination of segesterone acetate and ethinyl estradiol (SA/EE) effectively inhibits ovulation up to a year even at low systemic levels of SA, reports a review study presented at ENDO 2019.
17 Apr 2019
Non-alcoholic fatty liver disease (NAFLD) – a clinicopathological spectrum comprising hepatic steatosis or non-alcoholic fatty liver (NAFL) and non-alcoholic steatohepatitis (NASH) – is the hepatic manifestation of metabolic syndrome recognized as a leading cause of liver morbidity and mortality. Dr Loo Wai Mun, Consultant at the Division of Gastroenterology and Hepatology, National University Hospital, Singapore, speaks with Audrey Abella to discuss how NAFLD can be best managed in primary care.
Jairia Dela Cruz, 2 days ago
Rupatadine at either 10 or 20 mg delivers superior improvements in nasal and ocular symptoms of seasonal allergic rhinitis compared with placebo, with both doses well tolerated by adult and adolescent patients, according to the results of a phase III trial.

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
17 Apr 2019
The ketogenic and Modified Atkin’s diets are effective treatments for children with refractory epilepsy of genetic aetiology, a new study suggests.
Pearl Toh, 17 Apr 2019
A contraceptive vaginal system (Annovera) releasing a combination of segesterone acetate and ethinyl estradiol (SA/EE) effectively inhibits ovulation up to a year even at low systemic levels of SA, reports a review study presented at ENDO 2019.
17 Apr 2019
Non-alcoholic fatty liver disease (NAFLD) – a clinicopathological spectrum comprising hepatic steatosis or non-alcoholic fatty liver (NAFL) and non-alcoholic steatohepatitis (NASH) – is the hepatic manifestation of metabolic syndrome recognized as a leading cause of liver morbidity and mortality. Dr Loo Wai Mun, Consultant at the Division of Gastroenterology and Hepatology, National University Hospital, Singapore, speaks with Audrey Abella to discuss how NAFLD can be best managed in primary care.
Jairia Dela Cruz, 2 days ago
Rupatadine at either 10 or 20 mg delivers superior improvements in nasal and ocular symptoms of seasonal allergic rhinitis compared with placebo, with both doses well tolerated by adult and adolescent patients, according to the results of a phase III trial.