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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There have been studies that show how even low Dianabol doses, such as 15mg per day for 8 weeks, can decline testosterone levels by as much as 69%. That’s why post cycle therapy or PCT is very critical. This includes a drug like Nolvadex to stimulate natural testosterone production. This should last around 4-6 weeks after the end of the cycle to ensure that the body has started its normal testosterone production again and that hormones restore fully. If there is no proper PCT program followed, it is possible for the HPTA to shut down for good.