Most Read Articles
Jackey Suen, 08 Oct 2018

Adding pertuzumab to trastuzumab plus an aromatase inhibitor (AI) improves progression-free survival (PFS) in patients with HER2-positive metastatic or locally advanced breast cancer, the phase II PERTAIN study has shown.

Jackey Suen, 6 days ago

LCL161, an experimental inhibitor of apoptosis (IAP) protein antagonist, is shown to improve pathologic complete response (pCR) when added to paclitaxel in selected patients with localized triple-negative breast cancer (TNBC) in neoadjuvant settings.

01 Dec 2015
Colchine use in male Taiwanese patients with gout is associated with substantially reduced risk for cancer, as shown in a 12-year cohort study.

Original New Drug Application Approvals by US FDA (16 - 31 May 2018)

31 May 2018

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

LUCEMYRA

  • Active Ingredient(s): Lofexidine
  • Strength: 0.18 MG
  • Dosage Form: Tablet
  • Company: US Worldmeds LLC
  • Approval Date: 16 May 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults
  • Approved Label16/05/2018 (PDF)
AIMOVIG
  • Active Ingredient(s): Erenumab-AOOE
  • Strength: 70 MG/ML
  • Dosage Form: Injectable
  • Company: Amgen Inc
  • Approval Date: 17 May 2018
  • Submission Classification: Not available
  • Indication(s): Indicated for the preventive treatment of migraine in adults
  • Approved Label17/05/2018 (PDF)
LOKELMA
  • Active Ingredient(s): Sodium zirconium cyclosilicate
  • Strength: 5 G; 10 G
  • Dosage Form: Powder for oral suspension
  • Company: AstraZeneca Pharms
  • Approval Date: 18 May 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for hyperkalemia in adults
  • Approved Label18/05/2018 (PDF)
DOPTELET
  • Active Ingredient(s): Avatrombopag
  • Strength: 20 MG
  • Dosage Form: Tablet
  • Company: Akarx Inc
  • Approval Date: 21 May 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure
  • Approved Label: 21/05/2018 (PDF)
YONSA
  • Active Ingredient(s): Abiraterone acetate
  • Strength: 125 MG
  • Dosage Form: Tablet
  • Company: Sun Pharma Global
  • Approval Date: 22 May 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer 
  • Approved Label: 22/05/2018 (PDF)
PROGRAF
  • Active Ingredient(s): Tacrolimus
  • Strength: 0.2 MG; 1 MG
  • Dosage Form: Suspension
  • Company: Astellas
  • Approval Date: 24 May 2018
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants, in combination with other immunosuppressants
  • Approved Label: 24/05/2018 (PDF)
HALOBETASOL PROPIONATE
  • Active Ingredient(s): Halobetasol propionate
  • Strength:0.05%
  • Dosage Form: Fiber, extended release; periodontal
  • Company: Therapeutics Inc
  • Approval Date: 25 May 2018
  • Submission Classification: Type 3 - New Dosage Form and Type 4 - New Combination
  • Indication(s): Indicated for the topical treatment of plaque psoriasis in patients eighteen (18) years of age and older
  • Approved Label: 24/05/2018 (PDF)
PALYNZIQ
  • Active Ingredient(s): Pegvaliasee-PQPZ
  • Strength: 2.5MG/O.5ML; 10MG/0.5ML; 20MG/ML
  • Dosage Form: Injectable
  • Company: Biomarin Pharm
  • Approval Date: 25 May 2018
  • Submission Classification: Not available
  • Indication(s): Indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management
  • Approved Label: 24/05/2018 (PDF)
IMVEXXY
  • Active Ingredient(s): Estradiol
  • Strength:4 MCG; 10 MCG
  • Dosage Form: Vaginal insert
  • Company: TherapeuticsMD Inc
  • Approval Date:29 May 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause
  • Approved Label: 29/05/2018 (PDF)
CONSENSI
  • Active Ingredient(s): Amlodipine; Celecoxib
  • Strength: (2.5 MG; 200 MG); (5 MG; 200 MG); (10 MG; 200 MG)
  • Dosage Form: Tablet
  • Company: Kitov Pharmaceuticals
  • Approval Date: 31 May 2018
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated for patients for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis are appropriate
  • Approved Label: 31/05/2018 (PDF)
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Most Read Articles
Jackey Suen, 08 Oct 2018

Adding pertuzumab to trastuzumab plus an aromatase inhibitor (AI) improves progression-free survival (PFS) in patients with HER2-positive metastatic or locally advanced breast cancer, the phase II PERTAIN study has shown.

Jackey Suen, 6 days ago

LCL161, an experimental inhibitor of apoptosis (IAP) protein antagonist, is shown to improve pathologic complete response (pCR) when added to paclitaxel in selected patients with localized triple-negative breast cancer (TNBC) in neoadjuvant settings.

01 Dec 2015
Colchine use in male Taiwanese patients with gout is associated with substantially reduced risk for cancer, as shown in a 12-year cohort study.