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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
3 days ago
Administering intranasal desmopressin to patients with renal dysfunction not requiring haemodialysis reduces bleeding complications during renal biopsies, especially minor complications such as perinephric haematomas, a study has found. However, it may increase the risk of incident hyponatraemia.
Pearl Toh, 10 Oct 2019
Adding a LAMA* to the double combination therapy of ICS** plus LABA*** in a single inhaler improves lung function and reduces exacerbations in patients whose asthma is inadequately controlled with the combination treatment, according to the TRIMARAN and TRIGGER# studies presented at ERS 2019.
6 days ago
Environmental quality and exposure to pollution may play a small part in the development of metabolic diseases, such as diabetes, a new study has found.
5 days ago
Desmetramadol is able to provide the analgesic benefits of tramadol without the associated metabolic liabilities, according to a recent series of trials.