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Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “NEXSYMEO.”

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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.

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LifeProNow

APRIL 19, 2023

April 17, 2023: “The U.S. The most common adverse reactions associated with Omisirge included infections, GvHD, and infusion reactions. Treatment with Omisirge has the potential to cause severe side effects, which must be considered in assessing the risks and benefits of using this product.

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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.

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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)

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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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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].

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Adverse Reactions Packaging Labelling Diabetes 52