Most Read Articles
Yesterday
Routinely used for treating cardiovascular diseases, statins have been shown to benefit other conditions, and new evidence suggests that using the drug at high intensity reduces the risk of hip or knee replacement, an effect that may be specific to rheumatoid arthritis.
Pearl Toh, 29 Jun 2020
Having migraine during midlife appears to be associated with a higher risk of developing dementia in later life, according to a large population-based longitudinal Danish study presented at the AHS* 2020 Virtual Meeting, indicating that migraine may be a risk factor for dementia.
30 Jun 2020
Patients with psoriatic arthritis (PsA) often suffer from liver abnormalities, which are associated with higher body mass index (BMI), daily consumption of alcohol, more severe disease, and some therapies, according to a recent study.
Christina Lau, 5 days ago

Pembrolizumab in combination with chemotherapy significantly improves progression-free survival (PFS) vs chemotherapy alone in patients with previously untreated, locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC), results of the KEYNOTE-355 study have shown.

Original New Drug Application Approvals by US FDA (01 - 15 October 2019)

15 Oct 2019
New drug applications approved by US FDA as of 01 - 15 October 2019 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.

HEMADY
  • Active Ingredient(s): Dexamethasone
  • Strength: 20 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Dexcel Pharma
  • Approval Date: 03 October 2019
  • Submission Classification: Not available
  • Indication(s): Indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma.
  • Approved Label03 October 2019 (PDF)

AKLIEF
  • Active Ingredient(s): Trifarotene
  • Strength: 0.005%
  • Dosage Form(s) / Route(s): Cream; topical
  • Company: Galderma Research and Dev, Inc.
  • Approval Date: 04 October 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the topical treatment of acne vulgaris in patient 9 year of age and older.
  • Approved Label04 October 2019 (PDF)

BORTEZOMIB
  • Active Ingredient(s): Bortezomib
  • Strength: 3.5 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Dr. Reddy's Labs, Inc.
  • Approval Date: 04 October 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for:
    • treatment of adult patients with multiple myeloma.
    • treatment of adult patients with mantle cell lymphoma who have received at least 1 prior therapy.
  • Approved Label04 October 2019 (PDF)

QUZYTTIR
  • Active Ingredient(s): Cetirizine hydrochloride
  • Strength: 10 mg/mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: JDP Therapeutics, Inc.
  • Approval Date: 04 October 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of acute urticaria in adults and children 6 months of age and older.
  • Approved Label04 October 2019 (PDF)

BONSITY
  • Active Ingredient(s): Teriparatide
  • Strength: 20 mcg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Pfenex, Inc.
  • Approval Date: 04 October 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for:
    • Treatment of postmenopausal women with osteoporosis at high risk for fracture.
    • Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture.
    • Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture.
  • Approved Label04 October 2019 (PDF)

BEOVU
  • Active Ingredient(s): Brolucizumab-dbll
  • Strength: 6 mg/0.5 mL
  • Dosage Form(s) / Route(s): Injectable; intravitreal
  • Company: Novartis Pharms Corp.
  • Approval Date: 07 October 2019
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of Neovascular (Wet) Age-Related Macular Degeneration (AMD).
  • Approved Label07 October 2019 (PDF)

SCENESSE
  • Active Ingredient(s): Afamelanotide
  • Strength: 16 mg
  • Dosage Form(s) / Route(s): Implant; subcutaneous
  • Company: Clinuvel, Inc.
  • Approval Date: 08 October 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).
  • Approved Label08 October 2019 (PDF)

FLUORODEOXYPHENYLALANINE ([18F]-DOPA)
  • Active Ingredient(s): Fluorodeoxyphenylalanine
  • Strength: 185 MBq
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Feinstein
  • Approval Date: 10 October 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for use in positron emission tomography (PET) to visualize dopaminergic nerve terminals in the striatum for the evaluation of adult patients with suspected Parkinsonian syndromes (PS). Fluorodopa F 18 PET is an adjunct to other diagnostic evaluations.
  • Approved Label10 October 2019 (PDF)

REYVOW
  • Active Ingredient(s): Lasmiditan succinate
  • Strength: 50 mg; 100 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Eli Lilly and Co.
  • Approval Date: 11 October 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the acute treatment of migraine with or without aura in adults.
  • Approved Label11 October 2019 (PDF)

SECUADO
  • Active Ingredient(s): Asenapine
  • Strength: 3.8 mg; 5.7 mg; 7.6 mg
  • Dosage Form(s) / Route(s): System; transdermal
  • Company: Hisamitsu Pharm, Co.
  • Approval Date: 11 October 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Not available
  • Approved Label: Not available
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Most Read Articles
Yesterday
Routinely used for treating cardiovascular diseases, statins have been shown to benefit other conditions, and new evidence suggests that using the drug at high intensity reduces the risk of hip or knee replacement, an effect that may be specific to rheumatoid arthritis.
Pearl Toh, 29 Jun 2020
Having migraine during midlife appears to be associated with a higher risk of developing dementia in later life, according to a large population-based longitudinal Danish study presented at the AHS* 2020 Virtual Meeting, indicating that migraine may be a risk factor for dementia.
30 Jun 2020
Patients with psoriatic arthritis (PsA) often suffer from liver abnormalities, which are associated with higher body mass index (BMI), daily consumption of alcohol, more severe disease, and some therapies, according to a recent study.
Christina Lau, 5 days ago

Pembrolizumab in combination with chemotherapy significantly improves progression-free survival (PFS) vs chemotherapy alone in patients with previously untreated, locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC), results of the KEYNOTE-355 study have shown.