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Pearl Toh, 31 Dec 2019
Adding the neuraminidase inhibitor oseltamivir to usual care speeds up recovery from influenza-like illness by a day compared with usual care alone, with even greater benefits seen in older, sicker patients with comorbidities, according to the ALIC4E study.
23 Dec 2019
At a Menarini-sponsored symposium held during the Asian Pacific Society Congress, renowned cardiologist Prof John Camm provided the latest evidence for chronic stable angina with or without concomitant diseases, with a special focus on the antianginal agent ranolazine and combination therapies. The event was chaired and moderated by Dr Dante Morales from the University of the Philippines College of Medicine.
Pearl Toh, 13 Jan 2020
Obeticholic acid significantly improves fibrosis and disease activity in patients with nonalcoholic steatohepatitis (NASH), a chronic liver disease currently with no approved therapy, according to an interim analysis of the landmark REGENERATE* study.
Stephen Padilla, 6 days ago
The Lancet Commission on Hypertension Group has recently released a position statement that contains a list of recommendations for the improvement of accuracy standards for devices that measure blood pressure (BP).

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
Pearl Toh, 31 Dec 2019
Adding the neuraminidase inhibitor oseltamivir to usual care speeds up recovery from influenza-like illness by a day compared with usual care alone, with even greater benefits seen in older, sicker patients with comorbidities, according to the ALIC4E study.
23 Dec 2019
At a Menarini-sponsored symposium held during the Asian Pacific Society Congress, renowned cardiologist Prof John Camm provided the latest evidence for chronic stable angina with or without concomitant diseases, with a special focus on the antianginal agent ranolazine and combination therapies. The event was chaired and moderated by Dr Dante Morales from the University of the Philippines College of Medicine.
Pearl Toh, 13 Jan 2020
Obeticholic acid significantly improves fibrosis and disease activity in patients with nonalcoholic steatohepatitis (NASH), a chronic liver disease currently with no approved therapy, according to an interim analysis of the landmark REGENERATE* study.
Stephen Padilla, 6 days ago
The Lancet Commission on Hypertension Group has recently released a position statement that contains a list of recommendations for the improvement of accuracy standards for devices that measure blood pressure (BP).