pharmaphorum

MARCH 3, 2022

The findings – published today in the journal Nature Medicine – come after Jardiance was approved for chronic heart failure with reduced ejection fraction (HFrEF) last year, with the label expanded to include patients with heart failure with preserved ejection fraction (HFpEF) last month. It has been used to treat type 2 diabetes since 2014.

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Labelling Diabetes Hospitals 98

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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Labelling Adverse Reactions 52

pharmaphorum

OCTOBER 26, 2022

First approved back in 2014, it is still growing strongly, with its 2021 sales of €2.5 billion a 25% gain in the prior year and fuelled in part by extensions to its label to include other progressive ILDs.

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Labelling 98

pharmaphorum

SEPTEMBER 11, 2022

Analysts at Mizuho have suggested that competition from BMS’ drug could trim Otezla’s 2025 sales from $3 billion to $2 billion, although Amgen is attempting to defend its product by expanded the label of the drug to include mild psoriasis. It had been approved since 2014 for moderate to severe cases only.

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Labelling Immunity Immunization 52

RX Note

JUNE 8, 2023

In the past, package inserts were not always reliable sources of information regarding medication safety during lactation.

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Labelling Packaging 52

pharmaphorum

SEPTEMBER 21, 2020

The committee also recommended Lynparza should get its label extended to cover first-line maintenance treatment of ovarian cancer in combination with Roche’s Avastin (bevacizumab), in patients with homologous recombination deficient (HRD)-positive disease.

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Labelling Vaccines 52

pharmaphorum

MARCH 16, 2022

The Belgian biotech, which was spun out from the Vrije Universiteit Brussel in 2014, is developing a pipeline of radio-labelled, single-chain antibodies led by CAM-H2, currently in a phase 1/2 study in patients with HER2-positive metastatic breast and gastric cancers.

Labelling 59

Labelling 59

Pharmaceutical Technology

JANUARY 23, 2023

Out of the seven biologics approved to treat moderate to severe CD in adults, only the anti-TNFαs, Remicade (infliximab), and Humira (adalimumab), have been approved for paediatric patients, with Humira receiving the most recent approval in 2014.

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Compounding Labelling Drug Development 59

pharmaphorum

FEBRUARY 22, 2022

The FDA has approved expanded labelling for Abbott’s CardioMEMS HF System, an implantable sensor that provides an early warning of worsening heart failure, that could make it an option for more than a million more patients.

Labelling 64

Labelling 64

pharmaphorum

MARCH 8, 2021

The new indication for the Merck & Co/MSD-partnered drug – which is also used to treat ovarian, breast and pancreatic cancer – was approved by the EMA last year with a slightly more restricted label than was previous cleared by the FDA.

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pharmaphorum

AUGUST 4, 2021

The withdrawals – while voluntary – come as the FDA has been taking a closer look at accelerated approvals of cancer drugs, focusing mainly on checkpoint inhibitors that have seen new uses added to their labels at breakneck speed since being launched onto the market.

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Chemotherapy Labelling 98

Pharmaceutical Technology

JUNE 12, 2023

However, side effects known as amyloid-related imaging abnormalities, which often involve brain swelling, were also reported, and consequently the treatment has a warning on this specific side effect on its label.

Medical Schools 52

Medical Schools Labelling Drug Development 52

Syner-G

AUGUST 9, 2022

For each program, the RL represented the regulatory function on the PDT and coordinated the activities of a Regulatory Subteam, including members from CMC regulatory affairs, regulatory operations, labeling, and promotion and advertising. The drug was approved in 2014 and the RL is currently involved with NDA life-cycle activities.

Labelling 40

Labelling Pharmaceutical Companies Pharmaceutical Companies 40

Safe Biologics

NOVEMBER 12, 2023

FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars- Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S.

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Biosimilars Drug Pricing Packaging Labelling 130

pharmaphorum

JANUARY 10, 2022

Idorsia reckons Quviviq is a second-generation DORA with a profile that will be able to take on Eisai’s Dayvigo (lemborexant) and Merck & Co’s Belsomra (suvorexant), which were approved by the FDA in 2019 and 2014, respectively. The main side effects listed on its label are headache and – unsurprisingly – sleepiness.

Labelling 52

Labelling 52

pharmaphorum

FEBRUARY 23, 2021

Jakafi has been approved by the FDA in acute GVHD since 2019 and has been on the US market since 2011 for myelofibrosis and also picked up an indication in polycythemia vera in 2014. GVHD is a life-threatening complication following stem cell transplant to treat multiple myeloma and certain types of leukaemia and lymphoma.

Labelling 60

Labelling 60

Eye on FDA

AUGUST 2, 2022

And since 2014 the Office of Prescription Drug Promotion (OPDP) has broken double digits only 3 times, producing only 6 letters in both 2020 an 2021. In 1998, there were 156 letters issued in a single year. By 2002, the number had dropped to 28, reviving somewhat by the end of that decade when it reached 52 in 2010.

Communication 88

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 88

RX Note

MARCH 25, 2023

Dermatology Use (Off-label) When used in melasma , the reported success rate is up to 89%, with results appearing as early as 8 weeks. Dosage varies, according to the heaviness and duration of bleeding: 1 to 1.5 g 3 or 4 times daily for the first 3-5 days of each cycle.

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Dosage Labelling 40

ALiEM - Pharm Pearls

MARCH 7, 2024

Longitudinal view of the right kidney: Left – Probe placement in right mid-axillary line; Right – Unlabeled and labeled ultrasound view Video 1. 2014 Nov;22(4):213-22. Epub 2014 Nov 10. Identify the medullary pyramids, calyces, renal cortex, and renal pelvis (Figure 4). Transverse view of the right kidney Figure 4.

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Labelling Communication 177

The Thyroid Pharmacist

AUGUST 18, 2023

2014 Jul;69:182-201 [2] Prasad S, Aggarwal BB. Safety and efficacy of curcumin versus diclofenac in knee osteoarthritis: a randomized open-label parallel-arm study. 2014 Jul;69:182-201 [15] Prasad S, Aggarwal BB. 2014 Apr;10(38):106-10 [18] Bright JJ. 2014 Jul;69:182-201 [20] Kress, R. 2014 Jan; 46(1): 2–18. [22]

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Quality Matters

MARCH 1, 2024

Washington (DC): 2014; pharmacogenomics working group whose mission is to develop a 56. PGx presents opportunities for USP to collaborate with key stakeholders who are already developing PGx standards and guidelines and to apply its standards-setting process to establish alignment and consistency in PGx standards. Nature 520, 609–611 (2015).

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Labelling Compounding 52

European Pharmaceutical Review

DECEMBER 20, 2023

Figure 1: Changes in the European Commission’s proposal for pharmaceutical legislation fall under seven key themes, based on L.E.K. analysis (Source: L.E.K) In October 2023, the European Parliament (EP) proposed revisions to the European Commission proposals with diverging views on various topics set out through two documents.

Biosimilars 98

Biosimilars Labelling Documentation 98

European Pharmaceutical Review

JULY 5, 2022

In the future, the potential label expansion of Oncoral into other solid cancer indications will be investigated. accessdata.fda.gov/drugsatfda_docs/label/2014/020571s048lbl.pdf [Accessed 25.01.22]. Secondary endpoints will include response rate, overall survival, pharmacokinetics, safety and tolerability. About the author.

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Chemotherapy Dosage Labelling Compounding 104

pharmaphorum

DECEMBER 14, 2022

Amgen’s Blincyto (blinatumomab) was the first bispecific T cell engager to be approved for marketing way back in 2014, but has been a slow burner product for Amgen, with sales rising slowly to $472 million last year in its main indication in B-cell acute lymphoblastic leukaemia (B-ALL). years’ follow-up.

Mayo Clinic 52

Mayo Clinic Chemotherapy Labelling Hospitals 52

RX Note

JUNE 21, 2023

External Links Malaysian Consensus Guidelines on AntiRetroviral Therapy, 2017 Efficacy of 400 mg efavirenz versus standard 600 mg dose in HIV-infected, antiretroviral-naive adults (ENCORE1): a randomised, double-blind, placebo-controlled, non-inferiority trial, 2014 Dolutegravir versus ritonavir-boosted lopinavir both with dual nucleoside reverse transcriptase (..)

Labelling 52

Labelling 52

Syner-G

AUGUST 9, 2022

In addition, the IMPACT team worked very closely with the client in developing the key message points that needed to be addressed across all of the submission documents in support of the proposed label, and the IMPACT Project Manager provided input on ways to address a number of challenging clinical and regulatory issues within the application.

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Documentation Packaging Labelling 40

RX Note

MARCH 23, 2023

Today, stability information can be obtained from manufacturer’s labelling information (such as in the package insert), the USP compounding monographs, or peer-reviewed articles and references , such as articles in American Journal of Health-System Pharmacy, the International Journal of Pharmaceutical Compounding.

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Compounding Sterile Compounds Packaging Labelling 52

PharmaShots

APRIL 20, 2023

In August 2021, the FDA approved an expanded label for Lyumjev® (insulin lispro-aabc injection) 100 units/mL to include administration via continuous subcutaneous insulin infusion (CSII) with an insulin pump. The primary objective was noninferiority (noninferiority margin [NIM]=0.4%

Diabetes 40

Diabetes Labelling 40

Ramblings of a pharmacist

JUNE 28, 2022

This made sense to their workflow - by 2014 the overwhelming majority of prescriptions filled were for generics, so keeping sertraline in the Z’s didn’t make sense anymore. I’ll also add here that to make learning the shelving system easier for new employees, I have our computer system print the shelf number on our labels.

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Prescription Filling Labelling 52

Quality Matters

JUNE 26, 2023

Ensuring quality is essential Regulatory agencies and pharmacopeias around the world establish guidelines and requirements for generics manufacturers to follow in the manufacturing, testing, and labeling of their drug products to ensure they meet the same quality standards as the innovator product. Geneva: World Health Organization; 2014.

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Dosage Generic Medicine Labelling 52

Eye on FDA

JULY 7, 2020

The drug in question is Schedule II drug and bears a Boxed Warning on its label, yet the link contained no risk information about the drug, despite the fact that there was present information about the benefits of the drug, according to OPDP’s letter. One of them was about the appropriate use of links.

Communication 52

Communication Documentation Labelling Pharmaceutical Companies 52

European Pharmaceutical Review

JULY 4, 2024

However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. 1 For use as prescription drugs, a botanical product must be approved by the FDA: to date, only two have gained this approval. 2024 [cited 2024May]. Available from: [link] Barber S.

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Drug Development Biosimilars Documentation Compounding 103

The Nutrition Pharmacist

NOVEMBER 24, 2021

So, you could be cautious and select a supplement that contains activated folate, labelled as L-methylfolate or follinic acid. RANZCOG College Statement: C-Obs 25 2014. Important – some people have a gene mutation that leads to a folate deficiency, as the body cannot convert folate to the activated form.

Labelling 40

Labelling Diabetes 40

European Pharmaceutical Review

FEBRUARY 22, 2023

Results from the first open-label, single-centre study of RT-101,6 which was conducted in Australia, were reported at the start of 2020. He has been a key member of the executive team, most recently serving as the company’s Vice President, Strategy since 2014.

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Biosimilars Diabetes Immunity Immunization 105

European Pharmaceutical Review

AUGUST 15, 2024

BTKis, oral drugs given as continuous monotherapy, have revolutionised the treatment of CLL, with the first generation BTKi ibrutinib receiving European Medicines Agency (EMA) approval in 2014; however, side-effects (such as cardiovascular toxicities 2 ) have limited its suitability. The Lancet Oncology. 2020; 21(9):1188–200.

Labelling 52

Labelling 52

PharmaShots

APRIL 13, 2023

Abbott Laboratories spun off its branded pharmaceutical business into Abbvie Amgen acquired Onyx Pharmaceuticals to boost its portfolio of Immuno-Oncology Johnson & Johnson attained strong growth in 2014 with momentum in their pharmaceutical business and strong sales of their new core products contributing $32.2B to the revenue.

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Biosimilars Vaccines Pharmaceutical Companies Pharmaceutical Companies 40

Birth Control Pharmacist

SEPTEMBER 20, 2021

Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2021/214154s000lbl.pdf. OUP Academic , Oxford University Press, 5 July 2014, academic.oup.com/carcin/article/35/11/2447/416699. Accessed June 25, 2021. Nextstellis (Drospirenone and Estetrol) [package insert]. Food and Drug Administration website. Accessed April 2021. .

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Adverse Reactions Packaging Labelling Diabetes 52