After the Kefauver Harris Amendment was passed in 1962, the . FDA began the DESI review process to ensure the safety and efficacy of drugs approved under the more lenient pre-1962 standards, including Dianabol.  In 1965, the FDA pressured CIBA to further document its legitimate medical uses, and re-approved the drug for treating post-menopausal osteoporosis and pituitary-deficient dwarfism .  After CIBA's patent exclusivity period lapsed, other manufacturers began to market generic metandienone in the .
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