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Original New Drug Application Approvals by US FDA (16 - 31 March 2017)

31 Mar 2017
New drug applications approved by US FDA as of 16 - 31 March 2017 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.

LAMIVUDINE AND ZIDOVUDINE
  • Active Ingredient(s): LAMIVUDINE; ZIDOVUDINE
  • Strength: 150MG;300MG
  • Dosage Form: Oral Tablet
  • Company: Pharmacare LTD
  • Approval Date: March 17, 2017
  • Chemical Type: Type 4 - New Combination
  • Indication(s): Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection
  • Approved Label: 03/17/2017 (PDF)

XADAGO
  • Active Ingredient(s): SAFINAMIDE
  • Strength: 50MG; 100MG
  • Dosage Form: Oral Tablet
  • Company: Newron Pharms US Inc
  • Approval Date: March 21, 2017
  • Chemical Type: Type 1 - New Molecular Entity
  • Indication(s): Indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes
  • Approved Label: 03/21/2017 (PDF)

SYMPROIC
  • Active Ingredient(s): NALDEMEDINE
  • Strength: 0.2MG
  • Dosage Form: Oral Tablet
  • Company: Shionogi Inc
  • Approval Date: March 23, 2017
  • Chemical Type: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain
  • Approved Label: 03/23/2017 (PDF)

BAVENCIO
  • Active Ingredient(s): AVELUMAB
  • Strength: 20MG/ML
  • Dosage Form: Injectable; Injection
  • Company: EMD Serono Inc
  • Approval Date: March 23, 2017
  • Chemical Type: Not available
  • Indication(s): Indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC)
  • Approved Label: 03/23/2017 (PDF)

ZEJULA
  • Active Ingredient(s): NIRAPARIB
  • Strength: 100MG
  • Dosage Form: Oral Capsule
  • Company: Tesaro Inc
  • Approval Date: March 27, 2017
  • Chemical Type: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy
  • Approved Label: 03/27/2017 (PDF)

OCREVUS
  • Active Ingredient(s): OCRELIZUMAB
  • Strength: 30MG/1ML
  • Dosage Form: Injectable; Injection
  • Company: Genentech Inc
  • Approval Date: March 28, 2017
  • Chemical Type: Not available
  • Indication(s): Indicated for the treatment of patients with relapsing or primary progressive forms of multiple sclerosis
  • Approved Label: 03/28/2017 (PDF)

DUPIXENT
  • Active Ingredient(s): DUPILUMAB
  • Strength: 150MG/ML
  • Dosage Form: Injectable; Injection
  • Company: Regeneron Pharmaceuticals
  • Approval Date: March 28, 2017
  • Chemical Type: Not available
  • Indication(s): Indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.
  • Approved Label: 03/28/2017 (PDF)
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Most Read Articles
4 days ago
Blood pressure (BP) in children is influenced by early-life exposure to several chemicals, built environment and meteorological factors, suggests a study.
Jairia Dela Cruz, 06 Sep 2019
Low-dose dexamethasone and prednisolone are equally effective in the treatment of croup in children, according to data from the Topdog* trial.
4 days ago
Early brain injury and at least one sensorimotor immaturity precede cerebral palsy (CP) in very preterm infants and may be considered as reliable predictors, a recent study has found.
Jairia Dela Cruz, 04 Sep 2019
Parenteral antibiotic therapy duration for bacteraemic urinary tract infection (UTI) in young infants may be safely shortened, according to a recent study showing that recurrence and readmission or emergency department revisitation rates are comparable between a ≤7-day and a longer therapy course.