Faulding Hopes For FDA Approval

Australian drugmaker F H Faulding is hopeful that its Purepac manufacturing operation in the USA will soon gain approval from the Food and Drug Administration. The company's optimism is based on the fact that the FDA recently approved Purepac's generic naproxen, and it it not thought that this would have been done if the agency was not satisfied with Purepac's operations.

Meantime in Australia, Faulding has won the first round of a battle to introduce its ovarian and breast cancer drug Anzatax in competition with Bristol-Myers Squibb's Taxol (paclitaxel), when a federal court in Melbourne refused B-MS' injunction.

In addition, Faulding has entered into an agreement with Adelaide, Australia-based research organization, the CSIRO, for the development of new drug delivery technology. Each partner will spend A$4 million ($2.9 million) developing the technology, which will be used for a wide variety of drugs, according to Faulding's scientific affairs director, Julian Clark.