2023 Adverse Reactions Labelling 
European Pharmaceutical Review
OCTOBER 18, 2023
However, in the trials, the only observed adverse reaction for the treatment was diarrhoea. Further to the three Phase III trials for XPHOZAH, Ardelyx also declared that it has completed two open-label clinical trials (OPTIMIZE and NORMALIZE) to evaluate different options for integrating the treatment into clinical practice.
Big Molecule Watch
SEPTEMBER 25, 2023
Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “NEXSYMEO.”
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LifeProNow
MARCH 28, 2023
The most commonly reported adverse reaction was upper respiratory infections (18.9%), most frequently nasopharyngitis. The results are particularly meaningful for dermatologists and patients who have been waiting for a more effective and convenient oral therapy to help manage this serious, chronic, immune-mediated disease.” c 12 (7.2)
RX Note
JUNE 9, 2023
FDA Pregnancy and Lactation Labelling Final Rule, 2015 In the past, FDA Pregnancy Categories was used in US. To address this, on 13 December 2014, the FDA published the Pregnancy and Lactation Labelling Rule” (PLLR). Labelling for prescription drugs approved on or after June 30, 2001, will be phased in gradually.
Birth Control Pharmacist
SEPTEMBER 20, 2021
Adverse Reactions. The most common adverse reactions (>2%) were bleeding irregularities, dysmenorrhea, headaches, mood disturbance, increase weight, acne, decrease libido and breast symptoms. Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2021/214154s000lbl.pdf. Accessed June 25, 2021. 2020, [link].
The Thyroid Pharmacist
JUNE 30, 2023
Dr. Bernard Bihari is credited with making these discoveries about using naltrexone off-label, at lower doses. IW: What are some of the more common adverse reactions that people have to LDN? Published 2023 Mar 31. LDN is truly an intriguing drug. I have seen people be able to get rid of pain. Published 2018 Sep 21.
LifeProNow
APRIL 9, 2023
April 04, 2023: “Pfizer announced that the U.S. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in Fourth-Quarter 2023 for the sNDAs. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in Fourth-Quarter 2023 for the sNDAs. In the U.S.,
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