On 5th April, 2013 the Administrative Appeals Tribunal (AAT) decided that both Di-Gesic (dextropropoxyphene HCl 32.5 mg/paracetamol 325 mg) and Doloxene (dextropropoxyphene napsylate) should remain on the Australian Register of Therapeutic Goods (ARTG), subject to the implementation of conditions to promote the safe use of these medicines.
Di-Gesic and Doloxene continue to be registered on the Australian Register of Therapeutic Goods (ARTG) and doctors may continue to prescribe both products after carefully considering the indications, warnings and contraindications in the Product Information and Consumer Medicines Information for these products.
BUSPAR (buspirone hydrochloride) supply + future availability of buspirone through Special Access Scheme (SAS) Aspen is currently unable to manufacture Buspar due to ongoing technical challenges and, more recently, difficulties in sourcing the active ingredient.
Aspen will continue to appeal the Therapeutic Goods Administration‟s decision to de-register Di-Gesic and Doloxene.
The TGA has affirmed its decision to cancel the registration of DPP products, however its decision will not take effect until further order of the AAT. Aspen remains concerned to ensure that patients are not left without adequate pain relief, and considers that this is likely to be the case if Di-Gesic and Doloxene are de-registered. Consequently, Aspen will continue its appeal.
Di-Gesic and Doloxene will remain on the register while Aspen‟s appeal is heard and doctors may continue to prescribe both products after carefully considering the indications, warnings and contraindications in the Product Information and Consumer Medicines Information for these products.
Recognising the needs of a small group of patients who would be left without adequate pain relief if DiGesic and Doloxene were no longer available, the Administrative Appeals Tribunal (AAT) has declined to uphold a decision of the Minister/TGA to cancel the registrations of DiGesic and Doloxene.
Aspen has acquired a range of OTC products from GSK in a multi-territory transaction.
For Australia, the basket of products has sales of around $17 million, with about $750K in New Zealand. Other Asia-Pacific countries coming under the Aspen Australia umbrella represent sales of around $13.5 million.
The products in Australia are Cartia, Zantac, Lipeze, Quellada and Beconase, all well known power brands which will cement the position of Aspen Australia as one of the leading OTC companies in the country.
Aspen, Africa’s largest pharmaceutical manufacturer and the biggest listed pharmaceutical group in the health care sector of the Johannesburg Stock Exchange, through Aspen Pharmacare Australia, one of the leading pharmaceutical companies in Australia, aims to make high-quality branded medicine available to Filipino patients at affordable cost through the launch of its local subsidiary, Aspen Philippines.
The Australian Packaging Covenant is a voluntary initiative by Government and Industry to reduce the environmental effects of packaging. It is designed to minimise the environmental impacts arising from the disposal of used packaging, conserve resources through better design and production processes and facilitate the re-use and recycling of used packaging materials.
Here you can view Aspen Australia's plan and report.