ACPM identical drug alert
June 17, 2010
THE TGA’s Advisory Committee
on Prescription Medicines says it’s
concerned at the “apparent
proliferation in multiple trade
names for products which in all
other respects are indistinguishable,”
saying the practice raises serious
Quality Use of Medicines issues,
including increasing the potential
for prescriber and patient confusion.
The ACPM ratified a resolution
saying the matter of identical
products with different names but
the same sponsor, same active
ingredients, same dose forms and
same strengths needs to be brought
to the attention of the National
Medicines Policy Committee, and
has also recommended that the
TGA and external stakeholders
“should work together to formulate
a policy to help address this
extremely concerning practice”.
At its last meeting the committee
also recommended approval of:
• Orphan Australia’s Salofalk
(mesalazine) suppositories for
ulcerative proctitis.
• Novartis’ Riamet/Coartem
(artemether and lumefatrin)
dispersible tablet for malaria
• GE Healthcare’s Visipaque
(iodixanol) solution for injection
for use in children
• Genzyme Australia’s new entity
Mozobil (plerixafor) for
lymphoma and multiple myeloma.
• Extending the indication for
Pfizer’s Celebrex (celecoxib) for
short-term treatment of acute
pain in adults following surgery
or musculoskeletal and/or soft
tissue injury
• Shire Australia’s new Firazyr
(icatibant) injection for hereditary
angioedema
• An extended indication for Gilead
Sciences’ Hepsera (adefovir
dipvoxil) tablets for hepatitis B
• Novo Nordisk’s new Victoza
(liraglutide) injections as an
adjunct to diet and exercise for
adults with type 2 diabetes
• GSK’s new Votrient (pazopanib
hydrochloride) tablets for renal
cell carcinoma
• Schering-Plough’s new Sevikar
(olmesartan medoxomil and
amlodipine as besylate) tablets
for the treatment of hypertension
• GSK’s new Revolade
(eltrombopag olamine) for
tryombocytopaenic purpura
• A new formulation and dosage
change for GSK’s Pandemrix
H1N1 pandemic vaccine
• Commercial Eyes’ new Menveo
meningococcal vaccine
• A new strength and formulation
for Allergan’s Enidin P/Alphagan
P (brimonidine tartrate) eye drops
• Bayer’s new Visanne (dienogest)
tablet 2mg for endometriosis
• An extended indication for GSK’s
Tykerb (lapatinib) for breast
cancer
• Extended indications for Roche’s
Mabthera (rituximab) injections
for severe rheumatoid arthritis.
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