Obetrol

Obetrol was the brand of amphetamine mixed salts based drugs indicated for treatment of exogenous obesity by the American pharmaceutical company Obetrol Pharmaceuticals. Obetrol was a popular diet pill in America in the 1950s and 1960s. Obetrol was the brand of amphetamine mixed salts based drugs indicated for treatment of exogenous obesity by the American pharmaceutical company Obetrol Pharmaceuticals. Obetrol was a popular diet pill in America in the 1950s and 1960s. A formulation of amphetamine mixed salts that included methamphetamine was approved by the U.S. Food and Drug Administration (FDA) on January 19, 1960 under the name Obetrol. Between 1965 and 1973, this formula was offered in 10 mg and 20 mg strength through Obetrol Pharmaceuticals division of an American pharmaceutical company Rexar under the trade name Obetrol. Its indication was for exogenous obesity. In the 1950s, Obetrol was manufactured by Obetrol Pharmaceuticals, in Brooklyn, New York. The company later became a division of Rexar Pharmacal Corporation, which was also headquartered in Brooklyn. Sometime prior to 1972, Rexar Pharmacal moved its manufacturing facilities, including its Obetrol Pharmaceutical Division, to Valley Stream, New York. By the 1990s, Obetrol Pharmaceuticals had been wholly absorbed by Rexar Pharmacal and was no longer noted as a 'division' of Rexar. In 1993, Rexar was acquired by Richwood Pharmaceuticals of Florence, Kentucky, which in 1995 merged with Shire Pharmaceuticals. Per the 1972 Physicians' Desk Reference, Obetrol contained (per 10 mg tablet): Obetrol was also available in 20 mg. tablets which contained twice the quantity of its ingredients, in the same proportions. The 10 mg. tablets were blue, and the 20 mg were orange. Both were inscribed with the letters, 'OP'. Obetrol was withdrawn from the market in 1973 under DESI statute. Rexar reformulated Obetrol to exclude methamphetamine and continued to sell this new formulation under the same Obetrol brand name. This new unapproved formulation was later rebranded and sold as Adderall by Richwood after it acquired Rexar resulting in FDA warning in 1994. Richwood submitted this formulation as NDA 11-522 and Adderall gained FDA approval for the treatment of attention-deficit/hyperactivity disorder therapy on February 13, 1996. By the 1980s, the use of amphetamines—particularly methamphetamine—as an adjunct to diet and exercise in the treatment of exogenous obesity had become frowned upon by many in the medical community. As the decades evolved, so did the composition of Obetrol. By 1995, the year Shire Pharmaceuticals (then known as Shire-Richwood) acquired Rexar Pharmacal, Obetrol 10 mg. and 20 mg. tablets contained, (in equal proportions): These tablets were also blue and orange, but were inscribed with the letters, 'OB'.