Pharmaceutical Technology

MAY 12, 2023

As the next step in the FDA’s efforts to reduce prescription drug deaths , the agency is requiring updates to the boxed warning and other information for attention deficit hyperactivity disorder (ADHD) prescription stimulants. Prescription stimulants are used to treat ADHD, narcolepsy, and binge-eating disorder.

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Pharmaceutical Technology

MAY 11, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has voted unanimously in favour of giving HRA Pharma’s Opill (norgestrel) over-the-counter (OTC) availability. The FDA has no obligations to follow the recommendation of AdComs, though the vote will likely be weighed in the agency’s final decision.

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Pharmaceutical Technology

MAY 26, 2023

The FDA has flagged this issue as pharmacies selling prescription drugs illegally have proliferated over the years. The US Food and Drug Administration (FDA commissioner Dr. Robert Califf says, “The illegal sale of prescription drug stimulants online puts Americans at risk and contributes to potential abuse, misuse, and overdose.”

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Pharmaceutical Technology

MAY 15, 2023

If approved, the therapy could become the first FDA-approved gene transfer therapy for the condition. The FDA will assess the drug’s approval before its Prescription Drug User Fee Act (PDUFA) date on 29 May 2023. She said, “I wish the data were more persuasive”. Free Report How is the Biopharmaceutical industry evolving?

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Pharmaceutical Technology

MAY 9, 2023

New York-based Eyenovia has announced an FDA approval for Mydcombi (tropicamide and phenylephrine hydrochloride), the first ophthalmic spray for mydriasis or pupil dilation. The spray can be used for diagnostic procedures and conditions where short-term pupil dilation is necessary, such as cataract surgery or corrective prescriptions.

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Pharmaceutical Technology

DECEMBER 4, 2022

There are seven FDA-approved Humira biosimilars, of which Amgen’s Amjevita will be launched in January. At the same time, Cross says that this is not up to clinicians or the patients, but the payers. Product variation creates patient uncertainty. Citrate could also make these products unsatisfactory to the patients, says Cross.

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Pharmaceutical Technology

MARCH 16, 2023

Dr. Barry DeCoster, PhD, an associate professor of bioethics at the University of Michigan, describes gender affirming care as “safe and effective” for most patients. However, health specialists refute most safety concerns for the use of drug classes as part of gender affirming care, citing years of research and care.

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