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Approvals Action
Parkinson's drug passes muster
Posted 12 November 2018
Seqirus has registered its new Parkinsons' disease (PD) drug Xadago on the ARTG just in time for this month's PBAC consideration.
The company sought a major new listing as an add-on therapy to a regimen that includes levodopa (L-Dopa) for the treatment of fluctuating idiopathic PD in adults. The PBAC will publish its decision on reimbursement next month.
The drug's new product information document also includes a black triangle mark showing the therapy is under additional monitoring.
A total of five generics already PBS listed were also approved, three of which were sponsored by Sandoz and the remaining by Apotex and Sun Pharma.
Sandoz's Noumed Mirtazapine and Noumed Paroxetine are both indicated to treat major depression, whilst Esomeprazole Sz is indicated for the treatment of gastro-oesophageal reflux disease (GORD), forpatients requiring NSAID therapy, prevention of bleeding of gastric or duodenal ulcers, as well as pathological hypersecretory conditions.
Apotex's generic Apo-Risperidone is indicated for the treatment of schizophrenia and related psychoses and SunPharma's Abisart Hctz is indicated to treat hypertension.
NEW PRODUCTS
Product
Sponsor
ARTG Date
Link
XADAGO safinamide (as mesilate) 50, 100 mg film-coated tablet blister pack
Seqirus
2/11/2018
292144
FLUAD inactivated influenza vaccine (surface antigen) suspension for injection, adjuvanted, 0.5 mL syringe*
Seqirus
2/11/2018
306718
*New pack type
GENERICS ALREADY PBS LISTED
Product
Sponsor
ARTG Date
Link
APO-RISPERIDONE risperidone 0.5, 1, 2, 3, 4 mg tablet blister pack
Apotex
1/11/2018
304250
ESOMEPRAZOLE SZ esomeprazole (as magnesium) 20, 40 mg enteric-coated tablet blister pack
Sandoz
2/11/2018
309201
ABISART HCTZ 150/12.5, 300/12.5, 300/25 irbesartan 150, 300 mg + hydrochlorothiazide 12.5, 25 mg tablet blister pack
Sun Pharma
6/11/2018
302148
NOUMED MIRTAZAPINE mirtazapine 30, 45 mg tablet blister pack
Sandoz
7/11/2018
308469
NOUMED PAROXETINE paroxetine (as hydrochloride) 20 mg tablet blister pack
Sandoz
7/11/2018
308493
OTCs
Product
Sponsor
ARTG Date
Link
MENTHOLATUM ANTI-INFLAMMATORY PAIN RELIEF diclofenac sodium 10 mg/g gel tube
Soul Pattinson
2/11/2018
311043
AMCAL SORE THROAT SPRAY benzydamine hydrochloride 3 mg/mL pump actuated aerosol
Neo Health
2/11/2018
311044
BICOF CHESTY bromhexine hydrochloride 1.6mg/mL oral liquid bottle
Opal Pharmaceuticals
5/11/2018
311151
TERRYWHITE CHEMMART PERIOD PAIN RELIEF naproxen sodium 275mg tablet - film coated blister pack
Soul Pattinson
5/11/2018
311152
PHARMACY CHOICE EC ASPIRIN 100 aspirin 100mg enteric coated tablet blister pack (reformulation)
Symbion
6/11/2018
311187
ADVIL ibuprofen 200 mg soft capsule bottle
Pfizer
7/11/2018
311280
Tiffany Walker
Posted 12 November 2018
Seqirus has registered its new Parkinsons' disease (PD) drug Xadago on the ARTG just in time for this month's PBAC consideration.
The company sought a major new listing as an add-on therapy to a regimen that includes levodopa (L-Dopa) for the treatment of fluctuating idiopathic PD in adults. The PBAC will publish its decision on reimbursement next month.
The drug's new product information document also includes a black triangle mark showing the therapy is under additional monitoring.
A total of five generics already PBS listed were also approved, three of which were sponsored by Sandoz and the remaining by Apotex and Sun Pharma.
Sandoz's Noumed Mirtazapine and Noumed Paroxetine are both indicated to treat major depression, whilst Esomeprazole Sz is indicated for the treatment of gastro-oesophageal reflux disease (GORD), forpatients requiring NSAID therapy, prevention of bleeding of gastric or duodenal ulcers, as well as pathological hypersecretory conditions.
Apotex's generic Apo-Risperidone is indicated for the treatment of schizophrenia and related psychoses and SunPharma's Abisart Hctz is indicated to treat hypertension.
| NEW PRODUCTS | |||
| Product | Sponsor | ARTG Date | Link |
| XADAGO safinamide (as mesilate) 50, 100 mg film-coated tablet blister pack | Seqirus | 2/11/2018 | 292144 |
| FLUAD inactivated influenza vaccine (surface antigen) suspension for injection, adjuvanted, 0.5 mL syringe* | Seqirus | 2/11/2018 | 306718 |
*New pack type
| GENERICS ALREADY PBS LISTED | |||
| Product | Sponsor | ARTG Date | Link |
| APO-RISPERIDONE risperidone 0.5, 1, 2, 3, 4 mg tablet blister pack | Apotex | 1/11/2018 | 304250 |
| ESOMEPRAZOLE SZ esomeprazole (as magnesium) 20, 40 mg enteric-coated tablet blister pack | Sandoz | 2/11/2018 | 309201 |
| ABISART HCTZ 150/12.5, 300/12.5, 300/25 irbesartan 150, 300 mg + hydrochlorothiazide 12.5, 25 mg tablet blister pack | Sun Pharma | 6/11/2018 | 302148 |
| NOUMED MIRTAZAPINE mirtazapine 30, 45 mg tablet blister pack | Sandoz | 7/11/2018 | 308469 |
| NOUMED PAROXETINE paroxetine (as hydrochloride) 20 mg tablet blister pack | Sandoz | 7/11/2018 | 308493 |
| OTCs | |||
| Product | Sponsor | ARTG Date | Link |
| MENTHOLATUM ANTI-INFLAMMATORY PAIN RELIEF diclofenac sodium 10 mg/g gel tube | Soul Pattinson | 2/11/2018 | 311043 |
| AMCAL SORE THROAT SPRAY benzydamine hydrochloride 3 mg/mL pump actuated aerosol | Neo Health | 2/11/2018 | 311044 |
| BICOF CHESTY bromhexine hydrochloride 1.6mg/mL oral liquid bottle | Opal Pharmaceuticals | 5/11/2018 | 311151 |
| TERRYWHITE CHEMMART PERIOD PAIN RELIEF naproxen sodium 275mg tablet - film coated blister pack | Soul Pattinson | 5/11/2018 | 311152 |
| PHARMACY CHOICE EC ASPIRIN 100 aspirin 100mg enteric coated tablet blister pack (reformulation) | Symbion | 6/11/2018 | 311187 |
| ADVIL ibuprofen 200 mg soft capsule bottle | Pfizer | 7/11/2018 | 311280 |
Tiffany Walker
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