FDA Law Blog: Biosimilars

AUGUST 4, 2023

Because anabolic steroids are also abused to enhance athletic performance and increase muscle strength, Congress has enacted three laws regulating anabolic steroids: the Anabolic Steroid Control Acts of 1990 and 2004, and the Designer Anabolic Steroid Control Act of 2014 (“DASCA”). DASCA became law, amending the CSA, on December 18, 2014.

Controlled Substances

pharmaphorum

DECEMBER 22, 2021

Amgen has won FDA approval for a stronger label for its oral plaque psoriasis therapy Otezla, as it prepares for competition from Bristol-Myers Squibb’s much-touted rival deucravacitinib, which could make its debut next year. The post Amgen builds Otezla’s psoriasis label as rival BMS looms large appeared first on.

Labelling

FDA Law Blog: Biosimilars

OCTOBER 24, 2023

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). The SIUU Guidance, which supersedes the 2014 Draft GRP Guidance, is not substantially different in that regard and contains similar information as to the types of disclosures previously recommended.

Labelling

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.

Labelling

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.

Chemotherapy

Eye on FDA

JUNE 14, 2023

The numbers plummet in 2014 until the record low last year of only 4 letters. The label for the medicine includes a boxed warning regarding potential issues related to complications for the liver (toxicity) and heart (QT prolongation). The last letter issued came just over a year ago in June, 2022.

Labelling

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.

Chemotherapy

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.

Labelling

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.

Biosimilars

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

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

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

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]

Dosage

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.

Adverse Reactions

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.

Labelling

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.

Labelling

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

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

RX Note

JUNE 8, 2023

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

Labelling

Pharmaceutical Technology

NOVEMBER 30, 2022

The company’s weight loss drug Saxenda (liraglutide) won an approval for chronic weight management in December 2014, and Wegovy (semaglude) got the same tag in 2021. weight reduction in obese individuals, as per its label. Novo Nordisk is another company leading the charge in this field. compared to a 5.1%

Insurance Coverage and Processing

Pharmaceutical Technology

JANUARY 6, 2023

The agreement outlined that Par would keep its generic equivalent off the market for as many as two years, delaying the generic launch till September 30, 2014. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies. These actions allegedly led to the extension of Novartis’ patents.

Documentation

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

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

Pharmaceutical Technology

NOVEMBER 30, 2022

The company’s weight loss drug Saxenda (liraglutide) won an approval for chronic weight management in December 2014, and Wegovy (semaglude) got the same tag in 2021. weight reduction in obese individuals, as per its label. Novo Nordisk is another company leading the charge in this field. compared to a 5.1%

Insurance Coverage and Processing

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.

Dosage

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.

Biosimilars

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

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.

Compounding

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).

Labelling

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.

Documentation

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

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

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.

Drug Development

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.

Prescription Filling

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.

Dosage

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

The Thyroid Pharmacist

AUGUST 23, 2023

Published 2014 Dec 22. Thiamine and fatigue in inflammatory bowel diseases: an open-label pilot study. J Clin Gastroenterol. 2010;44(6):402-406. doi:10.1097/MCG.0b013e3181d6bc3e 0b013e3181d6bc3e [4] Stough C, Simpson T, Lomas J, et al. 2014;13(1):122. doi:10.1186/1475-2891-13-122 [5] Costantini A, Pala M. 2014;20(3):208-211.

Dosage