Most Read Articles
16 Oct 2014

Korean red ginseng (KRG), which is processed from raw ginseng, improves the quality of life of women by ameliorating oxidative stress induced by exposure to endocrine-disrupting bisphenol A (BPA), according to a recent study.

Roshini Claire Anthony, 05 Jan 2017

Only a third of women with polycystic ovary syndrome (PCOS) are satisfied with their diagnosis experience, according to results of a cross-sectional study.

Original New Drug Application Approvals by US FDA (1 - 15 May 2017)

15 May 2017
New drug applications approved by US FDA as of 1 - 15 May 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.

STERITALC
  • Active Ingredient(s): TALC
  • Strength: 2MG, 3MG, 4MG
  • Dosage Form: Topical Powder
  • Company: Novatech SA
  • Approval Date: May 1, 2017
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated:
    • To decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion.
    • In adults to decrease the recurrence of pneumothorax
  • Approved Label: 05/01/2017 (PDF)

IMFINZI
  • Active Ingredient(s): DURVALUMAB
  • Strength: 50MG/ML
  • Dosage Form: Injectable; Injection
  • Company: Astrazeneca UK Ltd
  • Approval Date: May 1, 2017
  • Chemical Type: Not available
  • Indication(s): Indicated for the treatment of patients with:
    • Locally advanced or metastatic urothelial carcinoma who:
      • have disease progression during or following platinum-containing chemotherapy
      • have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
  • Approved Label: 05/01/2017 (PDF)

KISQALI; FEMARA
  • Active Ingredient(s): LETROZOLE;RIBOCICLIB
  • Strength: 200MG
  • Dosage Form: Oral Tablet
  • Company: Novartis Pharms Corp
  • Approval Date: May 4, 2017
  • Chemical Type: Type 4 - New Combination
  • Indication(s): Indicated as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
  • Approved Label: 05/04/2017 (PDF)

RADICAVA
  • Active Ingredient(s): EDARAVONE
  • Strength: 30MG/100ML
  • Dosage Form: Injectable; Injection
  • Company: Mitsubishi Tanabe Pharma Development America Inc
  • Approval Date: May 5, 2017
  • Chemical Type: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of amyotrophic lateral sclerosis (ALS)
  • Approved Label: 05/05/2017 (PDF)

MINOLIRA
  • Active Ingredient(s): MINOCYCLINE HYDROCHLORIDE
  • Strength: 105MG, 135MG
  • Dosage Form: Extended release oral tablet
  • Company: Dr Reddys Labs Ltd
  • Approval Date: May 8, 2017
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older
  • Approved Label: 05/05/2017 (PDF)

BAVENCIO
  • Active Ingredient(s): AVELUMAB
  • Strength: 20MG/ML
  • Dosage Form: Injectable; Intravenoues
  • Company: EMD Serono Inc
  • Approval Date: May 9, 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)
    • Patients with locally advanced or metastatic urothelial carcinoma (UC) who:
      • Have disease progression during or following platinum-containing chemotherapy
      • Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
  • Approved Label: 05/09/2017 (PDF)
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Most Read Articles
16 Oct 2014

Korean red ginseng (KRG), which is processed from raw ginseng, improves the quality of life of women by ameliorating oxidative stress induced by exposure to endocrine-disrupting bisphenol A (BPA), according to a recent study.

Roshini Claire Anthony, 05 Jan 2017

Only a third of women with polycystic ovary syndrome (PCOS) are satisfied with their diagnosis experience, according to results of a cross-sectional study.