FDA OKs Marketing of Anti-Cancer Agent
International Pharmaceutical Products Inc. said it has received Food and Drug Administration approval to market a generic form of an injectable anti-cancer agent.
The fledgling Costa Mesa drug maker said the drug, Methotrexate, is used to treat acute lymphocytic leukemia, breast cancer, epidermoid cancers of the head and neck, and lung cancer.
The FDA action represents the first time the agency has approved a generic equivalent of Methotrexate, which has been available for several years. Marketing of the new generic drug to doctors and hospitals will begin June 1, the company said.
“We think it could be as much as a $1-million-a-year product for us,” said Lionel Simon, International Pharmaceutical’s president. Sales of the drug could reach the $1-million mark “within the next 12 months,” he said.
For the fiscal first half of 1986, International Pharmaceutical posted an operating loss of $1.1 million on revenues of $1.4 million. However, because of a $1.3-million settlement of a court case, the company reported net earnings of $165,000 for the six-month period.
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