The TGA has provided updated advice on the shortages of Anginine and Lycinate, as well as Clomid
Arrow Pharmaceuticals, the sponsor of Anginine and Lycinate tablets, has advised the TGA that shortages of the products are expected to continue until 15 January 2019.
“The TGA has granted approval to Pfizer Australia to supply Nitrostat 600 mcg (0.6 mg) and 300 mcg (0.3 mg) tablets sourced from the United States of America and also to HL Pharma to supply glyceryl trinitrate (GTN) 300 mcg tablets sourced from the United Kingdom,” the TGA advises.
“In addition to the previously approved alternative product, Nitrostat 600 mcg (0.6 mg)* and 300 mcg (0.3 mg) tablets sourced from the United States of America and supplied in Australia by Pfizer Australia, the TGA has also granted approval to HL Pharma to provide glyceryl trinitrate (GTN) 300 mcg tablets sourced from the United Kingdom.”
The TGA has also advised that the shortage of clomifene 50mg tablets (also known as clomiphene and marketed in Australia as Clomid) has been extended as well.
This product is expected to be available again after 30 September 2019, according to its sponsor, Sanofi-Aventis Australia.
Serophene, another name under which clomifene 50mg was marketed, was discontinued by its sponsor and removed from the market on 3 October 2016.
“The TGA has granted a section 19A approval for the import and supply of an alternative product Clomid (clomifene citrate) 50 mg tablets marketed in the Netherlands,” it says.
“Pharmacies can obtain the alternative Dutch product by ordering the product in the normal manner through the wholesaler, using the same wholesaler codes.”
Any adverse events involving the Dutch product should be reported directly to Sanofi or the TGA.
The TGA also pointed out that Sanofi is no longer supplying the previously approved alternative French product Clomid (clomifene citrate) 50 mg tablets.