2018 Adverse Reactions Labelling 
LifeProNow
APRIL 9, 2023
These sNDAs are supported by results from the PHAROS trial ( NCT03915951 ), an open-label, multicenter, non-randomized, Phase 2 study (n=98) to determine the safety, tolerability, and efficacy of BRAFTOVI given in combination with MEKTOVI in patients with BRAF V600E-mutant metastatic NSCLC. of patients.
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Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.”
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pharmaphorum
OCTOBER 19, 2020
The combination therapies had previously been marketed following accelerated approval in November 2018 on the basis of early stage results. The drug’s US label also covers certain patients with chronic lymphocytic leukaemia, including a chemotherapy-free regimen for previously untreated patients. months compared with 4.1
RX Note
FEBRUARY 11, 2024
Laboratory analysis of some homeopathic remedies found greater amounts of Atropa belladonna (deadly nightshade, an anticholinergic agent) than claimed on the label. Viscous lidocaine has been associated with serious adverse reactions ( including death ) in young children being treated for mouth pain, including teething.
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.
Quality Matters
OCTOBER 13, 2021
There are also related standards that address a wide range of topics such as packaging, storage and distribution of medicines, the preparation of compounded medicines and prescription labeling. This is what has been happening with nitrosamine impurities.
The Thyroid Pharmacist
SEPTEMBER 1, 2023
Who is Likely to Have an Adverse Reaction to Fluoride, and What are the Symptoms? Published 2018 Feb 8. Published 2018 Dec 9. Published 2018 Feb 8. Tea leaves accumulate fluoride from the soil, as well as from pollution. 30] If you live in the U.S., 2018;8(1):2674. Environ Adv. 2022;7:100135. doi:10.1016/j.envadv.2021.100135
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