Most Read Articles
29 Nov 2017
Rapid onset opioids may allow for more effective treatment of breakthrough cancer pain as their pharmacokinetic profile closely mimics the pain’s time course
Christina Lau, 22 Oct 2015
A 21-gene expression assay can identify patients with early-stage breast cancer who can skip adjuvant chemotherapy without facing an increased risk of recurrence at 5 years.
Elvira Manzano, 13 Sep 2017
Tisagenlecleucel, now US FDA approved, has made history as the first ever chimeric antigen receptor (CAR) T-cell therapy for B-cell precursor acute lymphoblastic leukaemia (ALL) – a breakthrough that has the potential to transform treatment for blood cancers that have not responded to standard therapies.
Naomi Adam, 01 Apr 2014

Colorectal cancer (CRC) is one of the most common cancers worldwide and its incidence is rising among Asians. Long-term survival outcomes are poor for CRC because patients often remain undiagnosed until the disease has reached an advanced stage. Panitumumab, a human IgG2 monoclonal antibody with high binding affinity for epidermal growth factor receptors, has shown encouraging results in the treatment of metastatic CRC (mCRC).

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

01 Jul 2014

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

BELEODAQ

  • Active Ingredient(s): Belinostat
  • Strength: 500 mg
  • Dosage Form: Lyophilized powder; Injection  
  • Company: SPECTRUM PHARMS
  • Approval Date: July 3, 2014
  • Indication(S): Indicated for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL)
  • Approved Label: 07/03/2014 (PDF)

  
KERYDIN

  • Active Ingredient(s): Tavaborole
  • Strength: 5%
  • Dosage Form: Solution; topical
  • Company: ANACOR PHARMS INC
  • Approval Date: July 7, 2014
  • Chemical Type: 1  New molecular entity (NME)
  • Indication(S): Indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.
  • Approved Label: 07/07/2014 (PDF)

  
RASUVO

  • Active Ingredient(s): Methotrexate
  • Strength: 7.5 mg, 10 mg, 12.5 mg, 15 mg, 17.5 mg, 20 mg, 22.5 mg, 25 mg, 27.5 mg, and 30 mg
  • Dosage Form: Injection
  • Company: MEDAC PHARMA INC
  • Approval Date: July 10, 2014
  • Chemical Type: 5  New formulation or new manufacturer
  • Indication(S): Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy; Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy.
  • Approved Label: 07/10/2014 (PDF)  

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Editor's Recommendations
Most Read Articles
29 Nov 2017
Rapid onset opioids may allow for more effective treatment of breakthrough cancer pain as their pharmacokinetic profile closely mimics the pain’s time course
Christina Lau, 22 Oct 2015
A 21-gene expression assay can identify patients with early-stage breast cancer who can skip adjuvant chemotherapy without facing an increased risk of recurrence at 5 years.
Elvira Manzano, 13 Sep 2017
Tisagenlecleucel, now US FDA approved, has made history as the first ever chimeric antigen receptor (CAR) T-cell therapy for B-cell precursor acute lymphoblastic leukaemia (ALL) – a breakthrough that has the potential to transform treatment for blood cancers that have not responded to standard therapies.
Naomi Adam, 01 Apr 2014

Colorectal cancer (CRC) is one of the most common cancers worldwide and its incidence is rising among Asians. Long-term survival outcomes are poor for CRC because patients often remain undiagnosed until the disease has reached an advanced stage. Panitumumab, a human IgG2 monoclonal antibody with high binding affinity for epidermal growth factor receptors, has shown encouraging results in the treatment of metastatic CRC (mCRC).