Published: 1 March 2018

Recent Approvals of Medicines Containing a New Active Ingredient

Prescriber Update 39(1): 5
March 2018

For period 16 October 2017 to 15 January 2018.

Trade Name (active ingredient)* Dose Form and Strength Therapeutic Area
Aldurazyme (laronidase) Concentrate for infusion 500 U/5 mL Mucopolysaccharidosis I (MPS I; alpha-L-iduronidase deficiency)
Alecensa (alectinib) Capsule 150 mg Anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC)
Belkyra (deoxycholic acid) Solution for injection 20 mg/2 mL (10 mg/mL) Improvement in appearance of submental fat in adults
Darzalex (daratumumab) Concentrate for infusion 100 mg/5mL and 400 mg/20 mL Multiple myeloma
Esmya (ulipristal) Tablet 5 mg Uterine fibroids
Glassia (alpha-1 proteinase inhibitor) Solution for injection 1000 mg/50 mL (20 mg/mL) Emphysema due to congenital deficiency of alpha1-proteinase inhibitor (alpha1-antitrypsin deficiency)
Hexvix (hexaminolevulinate) Powder for injection 85 mg with diluent Diagnostic use only. Used in cystoscopy to detect bladder cancer
Ocrevus (ocrelizumab) Concentrate for infusion 300 mg/10 mL Multiple sclerosis (MS)
Venclexta (venetoclax) Film coated tablet 10 mg Chronic lymphocytic leukaemia (CLL)
Xiaflex (collagenase clostridium histolyticum) Powder for injection 900 mcg Dupuytren's contracture and Peyronie's disease

* New active ingredient shown in bold type
Not available

The data sheets for currently marketed prescription medicines are published on the Medsafe website (