Most Read Articles
01 Dec 2020
Tetanus toxoid 5 Lf, diphtheria toxoid 2 Lf, pertussis toxoid 2.5 mcg, filamentous haemagglutinin 5 mcg, fimbriae types 2 and 3 5 mcg, pertactin 3 mcg
Dr. Hsu Li Yang, Dr. Tan Thuan Tong, Dr. Andrea Kwa, 08 Jan 2021
Antimicrobial resistance has become increasingly dire as the rapid emergence of drug resistance, especially gram-negative pathogens, has outpaced the development of new antibiotics. At a recent virtual symposium, Dr Hsu Li Yang, Vice Dean (Global Health) and Programme Leader (Infectious Diseases), NUS Saw Swee Hock School of Public Health, presented epidemiological data on multidrug-resistant (MDR) gram-negative bacteria (GNB) in Asia, while Dr Tan Thuan Tong, Head and Senior Consultant, Department of Infectious Diseases, Singapore General Hospital (SGH), focused on the role of ceftazidime-avibactam in MDR GNB infections. Dr Andrea Kwa, Assistant Director of Research, Department of Pharmacy, SGH, joined the panel in an interactive fireside chat, to discuss challenges, practical considerations, and solutions in MDR gram-negative infections. This Pfizer-sponsored symposium was chaired by Dr Ng Shin Yi, Head and Senior Consultant of Surgical Intensive Care, SGH.
Tristan Manalac, Yesterday
While antibody titres against SARS-CoV-2 wane with time, the immune system is capable of producing memory B-cells that can last for at least 6 months after infection, suggesting that the body will be able to protect itself in the case of re-exposure, according to a new study.
Jairia Dela Cruz, 5 days ago
Spending too much time sitting cannot be good for the body, and rising to one's feet breaks up such a behaviour and yields small, but meaningful, reductions in certain cardiovascular disease (CVD) risk factors, according to the results of a meta-analysis.

Original New Drug Application Approvals by US FDA (01 - 15 December 2020)

15 Dec 2020
New drug applications approved by US FDA as of 01 - 15 December 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.

GALLIUM GA 68 PSMA-11
  • Active Ingredient(s): PSMA-11 Ga 68
  • Strength: 18.5 MBq/mL to 185 MBq/mL (0.5 mCi/mL to 5 mCi/mL)
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: University of California, Los Angeles
  • Approval Date: 01 December 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:
    • with suspected metastasis who are candidates for initial definitive therapy.
    • with suspected recurrence based on elevated serum prostate-specific antigen.
  • Approved Label01 December 2020 (PDF)

HETLIOZ
  • Active Ingredient(s): Tasimelteon
  • Strength: 20 mg
  • Dosage Form(s) / Route(s): Capsule; oral
  • Company: Vanda Pharmaceuticals, Inc.
  • Approval Date: 01 December 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of:
    • Non-24-Hour Sleep-Wake Disorder (Non-24) in adults
    • Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older.
  • Approved Label01 December 2020 (PDF)

HETLIOZ LQ
  • Active Ingredient(s): Tasimelteon
  • Strength: 4 mg/mL
  • Dosage Form(s) / Route(s): Suspension; oral
  • Company: Vanda Pharmaceuticals, Inc.
  • Approval Date: 01 December 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of:
    • Non-24-Hour Sleep-Wake Disorder (Non-24) in adults
    • Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older
  • Approved Label01 December 2020 (PDF)

GAVRETO
  • Active Ingredient(s): Pralsetinib
  • Strength: 100 mg
  • Dosage Form(s) / Route(s): Capsule; oral
  • Company: Blueprint Medicines
  • Approval Date: 01 December 2020
  • Submission Classification: Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval
  • Indication(s): Indicated for treatment of:
    • Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC).
    • Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy.
    • Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
  • Approved Label01 December 2020 (PDF)

ORLADEYO
  • Active Ingredient(s): Berotralstat
  • Strength: 150 mg; 110 mg
  • Dosage Form(s) / Route(s): Capsule; oral
  • Company: Biocryst Pharmaceuticals, Inc.
  • Approval Date: 03 December 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.
  • Approved Label03 December 2020 (PDF)

KLISYRI
  • Active Ingredient(s): Tirbanibulin
  • Strength: 1%
  • Dosage Form(s) / Route(s): Ointment; topical
  • Company: Athenex, Inc.
  • Approval Date: 14 December 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the topical treatment of actinic keratosis of the face or scalp.
  • Approved Label14 December 2020 (PDF)
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Most Read Articles
01 Dec 2020
Tetanus toxoid 5 Lf, diphtheria toxoid 2 Lf, pertussis toxoid 2.5 mcg, filamentous haemagglutinin 5 mcg, fimbriae types 2 and 3 5 mcg, pertactin 3 mcg
Dr. Hsu Li Yang, Dr. Tan Thuan Tong, Dr. Andrea Kwa, 08 Jan 2021
Antimicrobial resistance has become increasingly dire as the rapid emergence of drug resistance, especially gram-negative pathogens, has outpaced the development of new antibiotics. At a recent virtual symposium, Dr Hsu Li Yang, Vice Dean (Global Health) and Programme Leader (Infectious Diseases), NUS Saw Swee Hock School of Public Health, presented epidemiological data on multidrug-resistant (MDR) gram-negative bacteria (GNB) in Asia, while Dr Tan Thuan Tong, Head and Senior Consultant, Department of Infectious Diseases, Singapore General Hospital (SGH), focused on the role of ceftazidime-avibactam in MDR GNB infections. Dr Andrea Kwa, Assistant Director of Research, Department of Pharmacy, SGH, joined the panel in an interactive fireside chat, to discuss challenges, practical considerations, and solutions in MDR gram-negative infections. This Pfizer-sponsored symposium was chaired by Dr Ng Shin Yi, Head and Senior Consultant of Surgical Intensive Care, SGH.
Tristan Manalac, Yesterday
While antibody titres against SARS-CoV-2 wane with time, the immune system is capable of producing memory B-cells that can last for at least 6 months after infection, suggesting that the body will be able to protect itself in the case of re-exposure, according to a new study.
Jairia Dela Cruz, 5 days ago
Spending too much time sitting cannot be good for the body, and rising to one's feet breaks up such a behaviour and yields small, but meaningful, reductions in certain cardiovascular disease (CVD) risk factors, according to the results of a meta-analysis.