2019 Controlled Substances FDA 
The FDA Law Blog
MAY 31, 2023
On May 24, 2019, Morris & Dickson paid a $22 million civil penalty related to the failure to report suspicious orders and ignoring certain red flags in the distribution of controlled substances. It has continued to serve customers who have relied on the distributor to supply controlled substances and other medicine.
pharmaphorum
OCTOBER 14, 2020
Wakix (pitolisant) was first approved in August 2019 for treatment of excessive sleepiness in adults with narcolepsy. It is the only FDA-approved drug to treat cataplexy associated with narcolepsy not scheduled as a controlled substance by the US Drug Enforcement Administration.
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pharmaphorum
DECEMBER 14, 2022
Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002. In 2020, the FDA-approved indication was expanded to include those patients who suffer from cataplexy.
European Pharmaceutical Review
DECEMBER 21, 2022
Most psychedelic drugs are Schedule I controlled substances, which means that very strict legal and regulatory controls accompany their use” Some psychedelics originate in nature and have been used by Indigenous cultures for thousands of years; others are manipulated or manufactured. Breakthrough therapy designation.
The Checkup by Singlecare
APRIL 25, 2024
Labeled as a controlled substance , Adderall contains amphetamine and dextroamphetamine. Food and Drug Administration ( FDA ). The FDA explains that their regulations require a proposed expiration date for medications to be approved. Pharmaceuticals have expiration dates. Adderall falls into this category.
The FDA Law Blog
FEBRUARY 27, 2024
156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. This means that there multiple same-day FDA NDA approvals for the same drug. FDA-2020-E-1840 (Mar.
The FDA Law Blog
NOVEMBER 15, 2022
He also held leading roles in DOJ’s response to multiple significant national health crises, including the COVID-19 pandemic, the 2019 EVALI vaping crisis, and the 2012 New England Compounding Center fungal meningitis outbreak.
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