International Pharmaceutical Products Inc. of Costa Mesa said Monday it has received Food and Drug Administration approval to sell a generic form of an anti-cancer drug that has been on the market for years.
The drug, 5-Fluorouracil (5-FU) Injection, was developed originally by Hoffman--LaRoche & Co., the Swiss drug firm, as a chemotherapy treatment for cancers of the colon, rectum, breast, stomach and pancreas. With the expiration of the patent several years ago, sale of generic equivalents of the drug were permitted.
International Pharmaceutical Products is the second company to introduce a generic equivalent of 5-FU, a drug with estimated total annual sales of $5 million. Hoffman-LaRoche is believed to command a 90% share of the sales of the drug and its equivalents.
Lionel Simon, IPP's co-founder and president, said the 5-FU equivalent is the first of several generic cancer treatments International Pharmaceutical Products intends to market. The drugs, he said, will be made by ABIC Ltd. in Israel and distributed in the United States by his company under an exclusive marketing agreement.
Simon said the FDA approval for the 5-FU product shows that ABIC's manufacturing facilities have met the FDA's standards for the making of sterile injectable products.
In addition to its anti-cancer generic drugs, IPP sells a line of eye, pet and sterile injectables made by its Maurry Biological operation in Los Angeles. International Pharmaceutical Products purchased Maurry Biological in late 1984.
The four-year-old company also is developing a product to treat gastric and duodenal ulcers with a new drug compound it licensed from the University of California in October, 1984. Research and development work on the drug is still under way.