European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

FDA

Pharmaceutical Technology

APRIL 11, 2023

This label expansion makes Orkambi the only disease-modifying CF medication available to patients of this age in Canada. This label expansion follows a similar label change in the US in September 2022. Health Canada is granting this new label expansion based on recent results from a Phase III study.

Labelling

Pharmaceutical Technology

APRIL 17, 2023

On 14 April 2023, experts from the US Food and Drug Administration’s (FDA) Advisory Committee (AdCom) voted largely in favour of the potential approval of Otsuka’ s and Lundbeck Pharmaceuticals’ Rexulti for the treatment of agitation associated with Alzheimer’s dementia (AAD). The FDA will consider the AdCom as it reviews the drug’s sNDA.

FDA

pharmaphorum

NOVEMBER 27, 2020

The new EU approval comes after the FDA approved the expanded label last year, and provides the first treatment option that tackles the underlying cause of CF in patients aged six to 11 with these mutations. Together these drugs cover the CFTR mutations seen in around half of all CF patients.

Labelling

The Checkup by Singlecare

OCTOBER 4, 2023

That’s why you may have seen people talk about a medication called Vyvanse, which is FDA approved to treat ADHD and binge eating disorder, as a good option for weight loss. In 2015, the FDA approved Vyvanse to be used in the treatment of binge eating disorder. Does Vyvanse cause weight loss?

Labelling

The FDA Law Blog

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. FDA further retained some definitions in the QSMR. Notably, Part 820 will look different. Revised § 820.3

FDA

The Checkup by Singlecare

JUNE 20, 2024

From 2015 to 2018, 13.2% Since Prozac (fluoxetine) was approved by the FDA in 1987, selective serotonin reuptake inhibitors (SSRIs) have been the most commonly prescribed antidepressants on the market. This is called off-label prescribing , and SSRIs rank among the top use cases for off-label use.

Labelling

pharmaphorum

DECEMBER 23, 2021

At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. Praluent meanwhile – which also made its debut in 2015 – is faring less well, bringing in €59 million ($67 million) for Sanofi and $45 million for Regeneron in the same period.

Labelling

European Pharmaceutical Review

JANUARY 25, 2023

Clinical trials for exa-cel The ongoing Phase I/II/III open-label trials, CLIMB-111 and CLIMB-121, are designed to assess the safety and efficacy of a single dose of exa-cel, the CRISPR-based medicine, in patients ages 12 to 35 years with TDT or with SCD, respectively. Costs and profits worldwide are shared with CRISPR Therapeutics.

Labelling

pharmaphorum

SEPTEMBER 15, 2021

The two FDA-approved oral GnRH antagonists – AbbVie and Neurocrine Biosciences’ Oriahnn (elagolix) and Myovant’s Pfizer-partnered Myfembree (relugolix) – are both combined with hormonal drugs. It licensed linzagolix from Japanese drugmaker Kissei in 2015 and has worldwide commercial rights, for the product outside Asia.

FDA

pharmaphorum

OCTOBER 30, 2022

Shares in US biotech Y-mAbs Therapeutics have lost almost a third of their value after FDA advisors unanimously rejected its brain cancer therapy 131I-omburtamab in 16 to 0 vote. Changes in standard and supportive care over the time period could also have skewed the results, said the FDA reviewer.

FDA

The FDA Law Blog

OCTOBER 5, 2022

By Riëtte van Laack — On September 28, 2022, FDA announced the availability of the proposed rule for the implied nutrient content claim “healthy.” The term healthy, as an implied nutrient claim, was first defined by FDA in 1994. FDA also announced it would be re-evaluating the regulatory criteria for use of the “healthy” claim.

FDA

The Checkup by Singlecare

JULY 8, 2024

It’s also relatively new: Vraylar came on the market in 2015, and the Food and Drug Administration (FDA) has been slowly approving it for different uses since then, including a 2022 approval for use alongside antidepressants in people with major depressive disorder. Can you take Vraylar while pregnant?

Labelling

The FDA Law Blog

AUGUST 11, 2024

The approved labeling for AUVI-Q includes warnings and precautions regarding emergency treatment, injection-related complications, serious infections at the injection site, allergic reactions associated with sulfite, and disease interactions. The website also included claims from “data on file” that were based on “pooled DOR” information.

Labelling

The Checkup by Singlecare

MAY 1, 2024

Food and Drug Administration (FDA) in 2007 for treatment and symptom control in ADHD. In 2015, Vyvanse was approved by the FDA also to treat binge eating disorder ( BED ). Generally speaking, the FDA approval process ensures no significant difference between brand and generic drugs.

Dosage

The Checkup by Singlecare

JANUARY 4, 2024

In addition, the FDA label for the nighttime forms of Mucinex containing acetaminophen recommends avoiding three or more drinks per day. In addition, the FDA advises against mixing alcohol with OTC medicines containing decongestants like pseudoephedrine or phenylephrine.

Immunization

Hospital Pharmacy Europe

MARCH 21, 2024

2 The first drug produced through printing technology based on inkjet on powder was approved by the US FDA in 2015. From translational to clinical research Between 2015 and 2023, very few human trials were described. Pharm J 2022 FDA approves the first 3D printed drug product.

Hospitals

Pharma Marketing Network

MARCH 25, 2022

The FDA has studied the importance of caregivers to drug development and regulatory decision-making. Pharma can help with caregiver-relevant labeling, training to perform nursing duties, and a multitude of other support services. Additional concerns for the caregiver include a strain on physical and mental health. What Can Pharma Do?

Labelling

The Checkup by Singlecare

FEBRUARY 1, 2024

Keep a regular schedule : Taking ibuprofen as directed by the label or a healthcare provider can help ensure the drug is taken effectively and safely. Read labels on nonprescription products: Check the labels of OTC cold and pain medications. Many products contain ibuprofen and other NSAIDs as added ingredients.

Labelling

The Checkup by Singlecare

MAY 24, 2024

Metformin hydrochloride is a generic drug approved by the Food and Drug Administration (FDA) to help manage blood sugar levels in people with type 2 diabetes mellitus. It can also be used off-label for weight loss. For weight loss, the only FDA-approved OTC weight-loss pill available is Alli (orlistat).

FDA

The Checkup by Singlecare

FEBRUARY 8, 2024

Clopidogrel and omega-3 fatty acids Omega-3 fatty acids are a popular dietary supplement, often labeled as fish oil capsules. Before you get too upset about this, check with your healthcare provider to see if any change in your coffee consumption is actually advised.

Labelling

pharmaphorum

AUGUST 9, 2022

Tagrisso meanwhile has been FDA-approved as a second-line treatment for EGFR T790M mutation-positive NSCLC since 2015, with its label extended since then to include first-line and adjuvant treatment. It is AZ’s biggest-selling drug, with sales topping $5 billion last year.

Chemotherapy

Hospital Pharmacy Europe

SEPTEMBER 29, 2022

The first oncolytic virus therapy to be approved by the FDA in 2015 was T-VEC for the treatment of patients with metastatic melanoma that cannot be surgically removed. The oncolytic effect of HSV and the inflammatory response that the virus stimulates provide a one-two punch at attacking tumours.

Immunization

Pharmaceutical Technology

JANUARY 6, 2023

In Par and Novartis’ agreement, Par gained exclusive rights to market its generic for six months after Novartis’ period of exclusivity finished, beginning September 30, 2014 and ending March 30, 2015. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies. Fighting Entresto generics.

Documentation

ISPE

JULY 19, 2023

™ started in 2015 at the ISPE Germany/Austria/Switzerland (D/A/CH) “Plug and Produce” workshop in Basel, Switzerland. Then in 2015, ISPE in Europe founded the Special Interest Group (SIG) Pharma 4.0™, Christian Wölbeling, Körber Pharma, Germany, gave an overview addressing where we are with Pharma 4.0. to a pharma-specific Pharma 4.0™

Documentation

The Checkup by Singlecare

DECEMBER 13, 2023

Be sure to follow the dosing instructions on the label for your child’s age. Kaopectate tablet and liquid suspension Bismuth subsalicylate is FDA-approved for treating nausea and vomiting. Antiemetic side effects Most OTC antiemetics are well-tolerated and safe if taken according to the labeled instructions.

Dosage

Druggist

MARCH 8, 2021

Taking ‘smart drugs’ in people with a modest level of cognitive function may lead to overconfidence (Nicholson, 2015). FDA (2010). Nicholson (2015). Improvement in this group of people may be more significant. Available at: [link] Accessed on 01/03/2021. PROVIGIL® (modafinil) Tablets [C-IV]. 2007;21(5):407-16.

FDA

DiversifyRx

JULY 11, 2024

Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. If the FDA or another regulator requests DSCSA transaction data, the DSCSA regulations give you up to 48 hours to respond. The original article can be found HERE.

Independent Pharmacies

The Thyroid Pharmacist

OCTOBER 7, 2022

Sure enough, she read all the labels on her supplements and in her pantry, and gave her kitchen a stevia-free makeover. Steviol glycosides, which are refined extracts of stevia, are recognized as safe by the Food and Drug Administration (FDA). May 21, 2015. Published 2015 Apr 2. What Are the Benefits of Stevia?

Immunization

The Checkup by Singlecare

MAY 1, 2025

Lamotrigine is the generic version of Lamictal, a medication thats FDA-approved to treat seizures as well as bipolar I disorder. Lamotrigine is sometimes prescribed off-label to treat schizophrenia, fibromyalgia, and trigeminal neuralgia. According to a 2015 meta-analysis, about 10% of people get a lamotrigine rash.

Labelling

pharmaphorum

AUGUST 25, 2021

It’s now globally accessible due to Gilead’s work with a network of generic manufacturers and their ability to sign licensing agreements just days after the US FDA registered its authorisation. In 2015, PEPFAR reached out to Gilead and said they were working with the government in Sub-Saharan Africa. Laying the groundwork.

Packaging

The Thyroid Pharmacist

DECEMBER 28, 2022

Then in 2015, I realized that we, the thyroid community, have the power to conduct our own research! In this article (which was originally published in 2015), we’ll dive into the results of the survey and discuss some important considerations for those with Hashimoto’s, including: How stress contributes to Hashimoto’s.

Immunization

The Checkup by Singlecare

DECEMBER 26, 2023

Dr. Cooperman warns consumers not to place too much trust in lion’s mane supplement labels. Food and Drug Administration (FDA) does not regulate nutritional supplements in the same way that it regulates medications. Sergio Alvarez, MD , CEO and medical director of Mia Aesthetics, agrees. Fr) Pers.

Immunization

The Checkup by Singlecare

DECEMBER 7, 2023

Melatonin for sleep The Food and Drug Administration (FDA) has not approved melatonin (nor any dietary supplement) for treating or managing sleep disorders. Younger children should not be given diphenhydramine unless instructed by a pediatrician. Also, warn parents that Benadryl could lead to increased arousal or hyperactivity in children.

Dosage

The Thyroid Pharmacist

JUNE 30, 2023

In 2015, I conducted a survey of over 2000 readers with Hashimoto’s , asking for the most helpful interventions in their health journeys. You may be familiar with naltrexone, which is an FDA-approved medication that has been used since the 1980s for opioid withdrawal. Have you heard of low dose naltrexone, or LDN?

Compounding

The Checkup by Singlecare

FEBRUARY 10, 2024

For example, participants of a study published in 2015 consumed ashwagandha and experienced a significant increase in muscle strength, with bench press improvements averaging around 101 lbs (46 kg) compared to around 57 lbs (26 kg) in the placebo group. Follow dosage instructions. Monitor for side effects. Check for proof of quality testing.

Dosage

The Checkup by Singlecare

APRIL 4, 2024

According to the United States Food and Drug Administration (FDA), taking Zyrtec with food won’t alter its effectiveness, but it may delay its peak concentration by 1.7 The FDA says Zyrtec’s effects typically last around 24 hours, and according to studies , its elimination half-life is around 8.3 How long does Zyrtec last?

Dosage