Generic drug manufacturers require the approval of the U.S. Food and Drug Administration to market a generic product. Lorazepam and clorazepate are two of the approximately 87 generic drugs that Mylan currently manufactures and sells in tablet form. Lorazepam, the generic version of Ativan, is used to treat anxiety, tension, agitation, and insomnia, and as a preoperative sedative. Doctors issue over 18 million prescriptions a year for lorazepam. Clorazepate, the generic version of Tranxene, is used to treat anxiety, as well as hypertension, and in adjunct therapy for nicotine and opiate withdrawal.
Doctors issue over three million clorazepate prescriptions a year.
Mylan, located in Pittsburgh, Pa., develops, licenses, manufactures, markets, and distributes generic and propriety pharmaceutical and wound care products. Cambrex, located in East Rutherford, N.J., manufactures and sells chemicals for pharmaceuticals, cosmetics, agriculture, and other industrial uses. Profarmaco, a wholly-owned subsidiary of Cambrex, is based in Milan, Italy. Profarmaco manufactures chemicals, including APIs, and sells them to drug manufacturers in the United States. Cambrex has ultimate control over the activities of Profarmaco, the FTC said.