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Miles Laboratories was founded as the Dr. Miles Medical Company in Elkhart, Indiana, in 1884 by Dr. Franklin Miles, a specialist in the treatment of eye and ear disorders, with an interest in the connection of the nervous system to overall health.

By 1890, the sales success of his patent medicine tonic, Dr. Miles' Nervine, in treating "nervous" ailments (including "nervousness or nervous exhaustion, sleeplessness, hysteria, headache, neuralgia, backache, pain, epilepsy, spasms, fits, and St. Vitus' dance") led him to develop a mail order medicine business. Miles also published Medical News, a thinly disguised marketing vehicle for Nervine. Nervine remained on the market as a "calmative" until the late 1960s.

In 1935, the name of the company was changed to Miles Laboratories.

In 1979, Bayer AG, whose original U.S. and Canadian aspirin business was seized as enemy property during World War I and World War II and subsequently sold as enemy assets, purchased Miles Laboratories and its subsidiary Miles Canada to reestablish a presence in North America, in the process also acquiring such products as Alka-Seltzer, Flintstones Vitamins, and One-A-Day Vitamins. Bayer continued to operate Miles Laboratories and developed many drugs based upon biological extracts, such as Kogenate, Gamimune-N and other immunoglobulins, and Trasylol, as well as diagnostic products such as blood glucose test strips and glucose meters. Miles also owned Cutter Biologicals, manufacturer of such diverse products as insect repellent and synthetic human Factor VIII clotting factor for hemophiliacs.

In 1992, Bayer AG moved the United States headquarters of Miles to Pittsburgh, Pennsylvania from Elkhart, and on April 1, 1995 Bayer eliminated the Miles brand name from all products and facilities after Bayer acquired Sterling Winthrop the previous year, thus reclaiming the North American rights to Bayer's name and trademarks as well as Bayer Aspirin.

Miles Laboratories also operated sites in other parts of the United States, including West Haven, Connecticut, which are now part of Bayer AG.