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Original New Drug Application Approvals by US FDA (01 - 15 November 2018)

15 Nov 2018
New drug applications approved by US FDA as of 01 - 15 November 2018 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.

SYMPAZAN
  • Active Ingredient(s): Clobazam
  • Strength: Not available
  • Dosage Form(s) / Route(s): Film; Oral
  • Company: Aquestive Therapeutics
  • Approval Date: 01 Nov 2018
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older
  • Approved Label01 Nov 2018 (PDF)

DSUVIA
  • Active Ingredient(s): Sufentanil
  • Strength: 30 MCG
  • Dosage Form(s) / Route(s): Tablet; Sublingual
  • Company: AcelRX Pharma Inc
  • Approval Date: 02 Nov 2018
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate
  • Approved Label02 Nov 2018 (PDF)

LORBRENA
  • Active Ingredient(s): Lorlatinib
  • Strength: 25 MG; 100 MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Pfizer Inc
  • Approval Date: 02 Nov 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on 
    • Icrizotinib and at least one other ALK inhibitor for metastatic disease; or
    • alectinib as the first ALK inhibitor therapy for metastatic disease; or 
    • ceritinib as the first ALK inhibitor therapy for metastatic disease. 
  • Approved Label: 02 Nov 2018 (PDF)

UDENYCA
  • Active Ingredient(s): Pegfilgrastim-CBQV
  • Strength: 6 MG / 0.6 ML
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Coherus Biosciences Inc
  • Approval Date: 02 Nov 2018
  • Submission Classification: Not Available
  • Indication(s): Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia
  • Approved Label: 02 Nov 2018 (PDF)

JEMDEL
  • Active Ingredient(s): Halobetasol Propionate
  • Strength: Not Available
  • Dosage Form(s) / Route(s): Not Available
  • Company: Dow Pharm
  • Approval Date: 06 Nov 2018
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the topical treatment of plaque psoriasis in adults
  • Approved Label: 06 Nov 2018 (PDF)

PRIMATENE MIST
  • Active Ingredient(s): Epinephrine
  • Strength: 125 MCG
  • Dosage Form(s) / Route(s): Aerosol; Inhalation
  • Company: Armstrong Pharms
  • Approval Date: 07 Nov 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the temporary relief of mild symptoms of intermittent asthma
  • Approved Label: 07 Nov 2018 (PDF)

YUPELRI
  • Active Ingredient(s): Revefenacin
  • Strength: 175 MCG / 3 ML
  • Dosage Form(s) / Route(s): Solution; Inhalation
  • Company: Theravance Biopharma
  • Approval Date: 09 Nov 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
  • Approved Label: 09 Nov 2018 (PDF)
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Most Read Articles
3 days ago
During the Allergic Rhinitis (AR) Boot Camp held in conjunction with the Bayer Pharmacist Congress 2020, Professor Dr Baharudin Abdullah discussed the management of AR in the primary care setting and the importance of using patient profiles to guide the choice of antihistamines.
Pank Jit Sin, 14 Apr 2020
With the movement control order (MCO) in full gear, most conferences and meetings are being postponed or cancelled. Some have taken to having conferences and meetings in a virtual setting, such as the recently ended American College of Cardiology/World Congress of Cardiology (ACC.20/WCC) conference. MIMS and the Asian Young Pharmacist Group (AYPG) took this opportunity to engage with pharmacists in the form of a Zoom meeting.