Most Read Articles
11 Aug 2020
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.
Elaine Soliven, 4 days ago
Adding mepolizumab to standard of care treatment significantly reduces nasal polyp size and obstruction in adults with chronic rhinosinusitis with nasal polyps (CRSwNP), according to the SYNAPSE* study presented at ERS 2020.
6 days ago
OZEMPIC – Semaglutide 1.34 mg/mL soln for inj
Audrey Abella, 11 Sep 2020
A prasugrel de-escalation strategy significantly reduced the risk of NACE* and bleeding events in patients with ACS** after PCI*** compared with the conventional strategy, results of the HOST-REDUCE-POLYTECH-ACS# trial have shown.

Original New Drug Application Approvals by US FDA (16 - 31 July 2020)

04 Aug 2020
New drug applications approved by US FDA as of 16 - 31 July 2020 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.

CARBON DIOXIDE, USP
  • Active Ingredient(s): Carbon dioxide
  • Strength: Not available
  • Dosage Form(s) / Route(s): Gas; inhalation
  • Company: Nexair LLC
  • Approval Date: 18 July 2020
  • Submission Classification: Not available
  • Indication(s): Not available
  • Approved Label: Not available

WYNZORA
  • Active Ingredient(s): Calcipotriene/betamethasone dipropionate
  • Strength: 0.005%/0.064%
  • Dosage Form(s) / Route(s): Cream; topical
  • Company: MC2 Therapeutics, Inc.
  • Approval Date: 20 July 2020
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older.
  • Approved Label20 July 2020 (PDF)

XYWAV
  • Active Ingredient(s): Calcium; magnesium; potassium; sodium oxybates
  • Strength: 0.5 mg/mL
  • Dosage Form(s) / Route(s): Solution; oral
  • Company: Jazz Pharms, Inc.
  • Approval Date: 21 July 2020
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
  • Approved Label21 July 2020 (PDF)

BREZTRI AEROSPHERE
  • Active Ingredient(s): Budesonide; formoterol fumarate; glycopyrrolate
  • Strength: 160 mcg/inh; 4.8 mcg/inh; 9 mcg/inh
  • Dosage Form(s) / Route(s): Aerosol, metered; inhalation
  • Company: Astrazeneca AB
  • Approval Date: 23 July 2020
  • Submission Classification: Not available
  • Indication(s): Indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
  • Approved Label23 July 2020 (PDF)

XEGLYZE
  • Active Ingredient(s): Abametapir
  • Strength: 0.74%
  • Dosage Form(s) / Route(s): Lotion; topical
  • Company: Dr Reddys Labs SA
  • Approval Date: 24 July 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the topical treatment of head lice infestation in patients 6 months of age and older. Xeglyze should be used in context of an overall lice management program:
    • Wash (with hot water) or dry-clean all recently worn clothing, hats, used bedding and towels
    • Wash personal care items such as combs, brushes and hair clips in hot water
    • Use a fine-tooth comb or special nit comb to remove dead lice and nits
  • Approved Label24 July 2020 (PDF)

CYCLOPHOSPHAMIDE
  • Active Ingredient(s): Cyclophosphamide
  • Strength: 500 mg/2.5 mL; 1 g/5 mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Ingenus Pharms, LLC
  • Approval Date: 30 July 2020
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for treatment of:
    • Malignant Diseases: malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma.
  • Approved Label30 July 2020 (PDF)

MONJUVI (TAFASITAMAB-CXIX) FOR INJECTION
  • Active Ingredient(s): Tafasitamab-cxix
  • Strength: 12 mg/kg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Morphosys US, Inc.
  • Approval Date: 31 July 2020
  • Submission Classification: Not available
  • Indication(s): Indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).
  • Approved Label31 July 2020 (PDF)
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Most Read Articles
11 Aug 2020
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.
Elaine Soliven, 4 days ago
Adding mepolizumab to standard of care treatment significantly reduces nasal polyp size and obstruction in adults with chronic rhinosinusitis with nasal polyps (CRSwNP), according to the SYNAPSE* study presented at ERS 2020.
6 days ago
OZEMPIC – Semaglutide 1.34 mg/mL soln for inj
Audrey Abella, 11 Sep 2020
A prasugrel de-escalation strategy significantly reduced the risk of NACE* and bleeding events in patients with ACS** after PCI*** compared with the conventional strategy, results of the HOST-REDUCE-POLYTECH-ACS# trial have shown.