Most Read Articles
Pearl Toh, 07 Aug 2018
A home-based, self-applied wearable electrocardiogram (ECG) patch facilitates diagnosis of atrial fibrillation (AF) among high-risk individuals, according to the mSToPS* trial.
Roshini Claire Anthony, 2 days ago

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

5 days ago

Fungal microbiome, also called the mycobiome, appears to be highly variable in patients with well-characterized fungal diseases, a recent study has shown. Moreover, severe asthmatics have the highest fungal loads, along with those receiving steroid and antifungal therapy.

Tristan Manalac, 4 days ago
The risk of complicated appendicitis is lower in children with IgE-mediated allergy, according to a recent study.

Original New Drug Application Approvals by US FDA (16 - 30 April 2016)

30 Apr 2016
New drug applications approved by US FDA as of 16 - 30 Apr 2016 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.

SIMVASTATIN
  • Active Ingredient(s): Simvastatin
  • Strength: 20MG/5ML, 40MG/5ML
  • Dosage Form: Oral solution
  • Company: Rosemont Pharmaceuticals Ltd
  • Approval Date: April 21, 2016
  • Chemical Type: 3  New dosage form
  • Indication(s): Indicated as an adjunctive therapy to diet to:
    • Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events
    • Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia
    • Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia
    • Reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia
    • Reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy
  • Approved Label: 04/21/2016 (PDF)

ORFADIN
  • Active Ingredient(s): Nitisinone
  • Strength: 4MG/ML
  • Dosage Form: Oral suspension
  • Company: Swedish Orphan
  • Approval Date: April 22, 2016
  • Chemical Type: 3  New dosage form
  • Indication(s): Indicated for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine
  • Approved Label: 04/22/2016 (PDF)

CABOMETYX
  • Active Ingredient(s): Cabozantinib (s)-malate
  • Strength: 20MG, 40MG, 60MG
  • Dosage Form: Oral tablet
  • Company: Exelixis Inc
  • Approval Date: April 25, 2016
  • Chemical Type: Not available
  • Indication(s): Indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti­angiogenic therapy
  • Approved Label: 04/25/2016 (PDF)

BEVESPI AEROSPHERE
  • Active Ingredient(s): Glycopyrrolate; Formoterol fumarate
  • Strength: 9/4.8MCG
  • Dosage Form: Metered aerosol inhalation
  • Company: Pearl Therapeutics Inc
  • Approval Date: April 25, 2016
  • Chemical Type: 4  New combination
  • Indication(s): Indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD)
  • Approved Label: 04/25/2016 (PDF)

TRIFERIC
  • Active Ingredient(s): Ferric pyrophosphate citrate
  • Strength: 272MG
  • Dosage Form: Oral solution
  • Company: Rockwell Medical Inc
  • Approval Date: April 25, 2016
  • Chemical Type: 3  New dosage form
  • Indication(s): Indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD)
  • Approved Label: 04/25/2016 (PDF)

XTAMPZA ER
  • Active Ingredient(s): Oxycodone
  • Strength: 9MG, 13.5MG, 18MG, 27MG, 36MG
  • Dosage Form: Extended-release oral capsule
  • Company: Collegium Pharms Inc
  • Approval Date: April 26, 2016
  • Chemical Type: 5  New formulation or new manufacturer
  • Indication(s): Indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate
  • Approved Label: 04/26/2016 (PDF)

ACTICLATE CAP
  • Active Ingredient(s): Doxycycline hyclate
  • Strength: 75MG
  • Dosage Form: Oral capsule
  • Company: Aqua Pharms
  • Approval Date: April 26, 2016
  • Chemical Type: 5  New formulation or new manufacturer
  • Indication(s): Indicated for:
    • Rickettsial infections
    • Sexually transmitted infections
    • Respiratory tract infections
    • Specific bacterial infections
    • Ophthalmic infections
    • Anthrax, including inhalational anthrax (post-exposure)
    • Alternative treatment for selected infections when penicillin is contraindicated
    • Adjunctive therapy for acute intestinal amebiasis and severe acne
    • Prophylaxis of malaria
  • Approved Label: 04/26/2016 (PDF)

NUPLAZID
  • Active Ingredient(s): Pimavanserin
  • Strength: 17MG
  • Dosage Form: Oral tablet
  • Company: Acadia Pharmaceuticals Inc
  • Approval Date: April 29, 2016
  • Chemical Type: 1  New molecular entity (NME)
  • Indication(s): Indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
  • Approved Label: 04/29/2016 (PDF)

AZACITIDINE
  • Active Ingredient(s): Azacitidine
  • Strength: 100MG
  • Dosage Form: Injectable, injection
  • Company: Actavis LLC
  • Approval Date: April 29, 2016
  • Chemical Type: 5  New formulation or new manufacturer
  • Indication(s): Indicated for the treatment of patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL)
  • Approved Label: 04/29/2016 (PDF)

OTOVEL
  • Active Ingredient(s): Ciprofloxacin; Fluocinolone acetonide
  • Strength: 0.3%; 0.025%
  • Dosage Form: Otic solution/drops
  • Company: Laboratorios Salvat SA
  • Approval Date: April 29, 2016
  • Chemical Type: 5  New formulation or new manufacturer
  • Indication(s): Indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa
  • Approved Label: 04/29/2016 (PDF)

FYCOMPA
  • Active Ingredient(s): Perampanel
  • Strength: 2MG, 4MG, 6MG, 8MG, 10MG, 12MG
  • Dosage Form: Oral suspension
  • Company: Eisai Inc
  • Approval Date: April 29, 2016
  • Chemical Type: 3  New dosage form
  • Indication(s): Indicated as adjunctive therapy for the treatment of:
    • Partial-Onset Seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older
    • Primary Generalized Tonic-Clonic Seizures in patients with epilepsy 12 years of age and older
  • Approved Label: 04/29/2016 (PDF)

AKOVAZ
  • Active Ingredient(s): Ephedrine sulfate
  • Strength: 50MG/ML
  • Dosage Form: Injectable, injection
  • Company: Flamel Ireland LTD
  • Approval Date: April 29, 2016
  • Chemical Type: 7  Drug already marketed without an approved NDA
  • Indication(s): Indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia
  • Approved Label: 04/29/2016 (PDF)

Related MIMS Drugs

Digital Edition
Asia's trusted medical magazine for healthcare professionals. Get your MIMS Oncology - Malaysia digital copy today!
Sign In To Download
Editor's Recommendations
Most Read Articles
Pearl Toh, 07 Aug 2018
A home-based, self-applied wearable electrocardiogram (ECG) patch facilitates diagnosis of atrial fibrillation (AF) among high-risk individuals, according to the mSToPS* trial.
Roshini Claire Anthony, 2 days ago

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

5 days ago

Fungal microbiome, also called the mycobiome, appears to be highly variable in patients with well-characterized fungal diseases, a recent study has shown. Moreover, severe asthmatics have the highest fungal loads, along with those receiving steroid and antifungal therapy.

Tristan Manalac, 4 days ago
The risk of complicated appendicitis is lower in children with IgE-mediated allergy, according to a recent study.