Most Read Articles
Roshini Claire Anthony, 6 days ago

A genotype-guided approach to warfarin dosing may result in fewer dose adjustments in Asian patients, according to a study from Singapore.

6 days ago
Patients with coronary artery disease (CAD) treated in a poor Southeast Asian setting appear to have far too high short-term and medium-term mortality rates, according to a study.
21 Jul 2018
Although many patients with atopic dermatitis (AD) use antihistamines, no high-level evidence exists to prove that nonsedating antihistamines reduce itch in patients with AD or provide benefit in controlling AD symptoms, except perhaps sleep and AD comorbidities such as allergic rhinitis, according to a study.
4 days ago
Supplementation with conjugated linoleic acid appears to increase inflammatory markers such as C-reactive protein and tumour necrosis factor-α, according to a recent meta-analysis.

Original New Drug Application Approvals by US FDA (16 – 31 Dec 2015)

31 Dec 2015
New drug applications approved by US FDA as of 16 - 31 Dec 2015 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.

BASAGLAR
  • Active Ingredient(s): Insulin glargine
  • Strength: 100 UNITS/ML
  • Dosage Form: Injectable;Injection
  • Company: Eli Lilly and Co
  • Approval Date: December 16, 2015
  • Chemical Type: 5 New formulation or new manufacturer
  • Indication(s): Indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus
  • Approved Label: 12/16/2015 (PDF)

EMEND
  • Active Ingredient(s): Aprepitant
  • Strength: 125MG
  • Dosage Form: Oral solution
  • Company: Merck Sharp Dohme
  • Approval Date: December 17, 2015
  • Chemical Type: 3 New dosage form
  • Indication(s): Indicated in combination with other antiemetic agents, in patients 6 months of age and older for prevention of: a) acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin; b) nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC)
  • Approved Label: 12/17/2015 (PDF)

UPTRAVI
  • Active Ingredient(s): SELEXIPAG
  • Strength: 200MCG, 400MCG, 600MCG, 800MCG, 1000MCG, 1200MCG, 1400MCG, 1600MCG
  • Dosage Form: Oral tablet
  • Company: ACTELION PHARMS LTD
  • Approval Date: December 21, 2015
  • Chemical Type: 1 New molecular entity (NME)
  • Indication(s): Indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH.
  • Approved Label: 12/21/2015 (PDF)

DOCETAXEL
  • Active Ingredient(s): DOCETAXEL
  • Strength: 20MG/ML, 80MG/4ML, 160MCG/8ML
  • Dosage Form: Injectable injection
  • Company: TEIKOKU PHARMA USA
  • Approval Date: December 22, 2015
  • Chemical Type: 5 New formulation or new manufacturer
  • Indication(s): Indicated for a) Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC; b) Non-Small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC; c) Hormone Refractory Prostate Cancer (HRPC): with prednisone in androgen independent (hormone refractory) metastatic prostate cancer; d) Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction; e) Squamous Cell Carcinoma of the Head and Neck Cancer (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN
  • Approved Label: 12/22/2015 (PDF)

ZURAMPIC
  • Active Ingredient(s): LESINURAD
  • Strength: 200MG
  • Dosage Form: Oral tablet
  • Company: ARDEA BIOSCIENCES INC
  • Approval Date: December 22, 2015
  • Chemical Type: 1 New molecular entity (NME)
  • Indication(s): Indicated in combination with a xanthine oxidase inhibitor for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone
  • Approved Label: 12/22/2015 (PDF)

ZOLEDRONIC ACID
  • Active Ingredient(s): ZOLEDRONIC ACID
  • Strength: 4MG/100ML
  • Dosage Form: Injectable injection
  • Company: HOSPIRA INC
  • Approval Date: December 28, 2015
  • Chemical Type: 5 New formulation or new manufacturer
  • Indication(s): Indicated for for the treatment of: (a) Hypercalcemia of malignancy; (b) Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy
  • Approved Label: 12/28/2015 (PDF)

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Most Read Articles
Roshini Claire Anthony, 6 days ago

A genotype-guided approach to warfarin dosing may result in fewer dose adjustments in Asian patients, according to a study from Singapore.

6 days ago
Patients with coronary artery disease (CAD) treated in a poor Southeast Asian setting appear to have far too high short-term and medium-term mortality rates, according to a study.
21 Jul 2018
Although many patients with atopic dermatitis (AD) use antihistamines, no high-level evidence exists to prove that nonsedating antihistamines reduce itch in patients with AD or provide benefit in controlling AD symptoms, except perhaps sleep and AD comorbidities such as allergic rhinitis, according to a study.
4 days ago
Supplementation with conjugated linoleic acid appears to increase inflammatory markers such as C-reactive protein and tumour necrosis factor-α, according to a recent meta-analysis.