Most Read Articles
19 Sep 2018
In advanced-stage, newly diagnosed classical, CD30-positive Hodgkin lymphoma (HL), front-line therapy has resulted in durable remission rates in up to 70–90% of patients, although approximately 25–30% of advanced stage HL patients are refractory or relapse following first-line treatment with ABVD (adriamycin, bleomycin, vinblastine, dacarbazine) chemotherapy.1–3 The standard of care for patients with relapsed or refractory (r/r) classical HL is salvage therapy using second-line high-dose chemotherapy (HDCT), followed by autologous haematopoietic stem cell transplant (ASCT) in eligible patients, which can induce a complete remission (CR) in about 50% of patients.4 Nevertheless, the prognosis of patients who relapse after the salvage HDCT/ASCT is exceedingly poor, with a median survival duration of approximately 1.2 years.5
Elaine Soliven, 28 Jun 2019
Adjuvant treatment with ipilimumab significantly improved overall survival (OS) among patients with resected high-risk melanoma compared with high-dose interferon-α2b (HDI*), according to final results of the North American Intergroup E1609** trial presented at ASCO 2019.
Elaine Soliven, 18 Jun 2019
Neoadjuvant treatment with trastuzumab emtansine (T-DM1) plus pertuzumab led to an elevated risk of 3-year event-free survival (EFS) events in patients with HER2-positive breast cancer, according to a secondary analysis of the KRISTINE* trial presented at ASCO 2019.
Audrey Abella, 14 Jun 2019
The taxane-based TPEx regimen demonstrated encouraging overall survival (OS) benefit for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) compared with the fluorouracil (5FU)-based EXTREME regimen, according to the results of the TPExtreme* trial presented at ASCO 2019.

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

16 Oct 2017
New drug applications approved by US FDA as of 1 - 15 October 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.

ASCOR
  • Active Ingredient(s): ASCORBIC ACID
  • Strength: 500MG/ML
  • Dosage Form: Injectable;Injection
  • Company: Mcguff Pharmaceuticals Inc
  • Approval Date: October 2, 2017
  • Submission Classification: Type 7 - Drug Already Marketed without Approved NDA
  • Indication(s): Indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated
  • Approved Label: 10/02/2017 (PDF)

ZILRETTA
  • Active Ingredient(s): TRIAMCINOLONE ACETONIDE
  • Strength: 32MG
  • Dosage Form: Intramuscular extended-release injectable suspension
  • Company: Flexion Therapeutics Inc
  • Approval Date: October 6, 2017
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated as an intra-articular injection for the management of osteoarthritis pain of the knee
  • Approved Label: 10/06/2017 (PDF)

LYRICA CR
  • Active Ingredient(s): PREGABALIN
  • Strength: 82.5MG | 165MG | 330MG
  • Dosage Form: Extended release oral tablet
  • Company: Pfizer Inc
  • Approval Date: October 11, 2017
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the management of:
    • Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
    • Postherpetic neuralgia (PHN)
  • Approved Label: 10/11/2017 (PDF)

FOSAPREPITANT
  • Active Ingredient(s): FOSAPREPITANT
  • Strength: 150MG/VIAL
  • Dosage Form: Injectable;Injection
  • Company: Teva Pharms USA Inc
  • Approval Date: October 12, 2017
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the prevention of:
    • Acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin
    • Delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC)
  • Approved Label: Not available
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Most Read Articles
19 Sep 2018
In advanced-stage, newly diagnosed classical, CD30-positive Hodgkin lymphoma (HL), front-line therapy has resulted in durable remission rates in up to 70–90% of patients, although approximately 25–30% of advanced stage HL patients are refractory or relapse following first-line treatment with ABVD (adriamycin, bleomycin, vinblastine, dacarbazine) chemotherapy.1–3 The standard of care for patients with relapsed or refractory (r/r) classical HL is salvage therapy using second-line high-dose chemotherapy (HDCT), followed by autologous haematopoietic stem cell transplant (ASCT) in eligible patients, which can induce a complete remission (CR) in about 50% of patients.4 Nevertheless, the prognosis of patients who relapse after the salvage HDCT/ASCT is exceedingly poor, with a median survival duration of approximately 1.2 years.5
Elaine Soliven, 28 Jun 2019
Adjuvant treatment with ipilimumab significantly improved overall survival (OS) among patients with resected high-risk melanoma compared with high-dose interferon-α2b (HDI*), according to final results of the North American Intergroup E1609** trial presented at ASCO 2019.
Elaine Soliven, 18 Jun 2019
Neoadjuvant treatment with trastuzumab emtansine (T-DM1) plus pertuzumab led to an elevated risk of 3-year event-free survival (EFS) events in patients with HER2-positive breast cancer, according to a secondary analysis of the KRISTINE* trial presented at ASCO 2019.
Audrey Abella, 14 Jun 2019
The taxane-based TPEx regimen demonstrated encouraging overall survival (OS) benefit for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) compared with the fluorouracil (5FU)-based EXTREME regimen, according to the results of the TPExtreme* trial presented at ASCO 2019.