#FDA approved generics

[emily-space]

Should you consider switching from brand-name to generics?

 Choosing generic medicines can save you money while ensuring you receive safe and effective treatment. Generic drugs are identical to brand-name drugs in dosage, safety, and strength, meeting the same rigorous FDA standards. They are often much cheaper because they don't carry the high development costs of brand-name drugs. At DiRx, we help you find affordable generic options, ensuring you get the best value for your healthcare needs.

[larkiethings]

I was writing this in the tags but I want to include sources. I’m gonna tell you why drugs don’t go generic right away, and I want you to know that I don’t agree with the reasoning here, but this is how the system works.

New drugs are priced so much to recoup some of the losses of research. Drug research is insanely expensive. Whether you’re talking about buffers and reagents in the lab, machines designed to give scientists highly specific information, or required animal research, it’s EXPENSIVE. I tried to pull up an example for a standard microscope but companies that make lab equipment don’t have prices on their website, you have to fill out a form to request a quote.

So, lab equipment is expensive. You also have to go through rounds of animal testing. One lab mouse can cost hundreds of dollars, depending on how it has been genetically designed to give the best research results. And spoiler alert, you need repeat results, meaning multiple mice, and then larger lab animals because humans aren’t mice and we need to be sure drugs are safe before testing them on humans. Raising and caring for lab animals also takes lots of highly trained staff, which adds to the expense. This is partially why a lot of scientists in animal research are pushing for alternative research methods, because it is more humane and more cost effective to reduce our reliance on animal models.

So it’s expensive to do research, and then you get into patent law. Drugs get 20 years of patents, although that’s from when the patent was filed - which is often BEFORE the drug hits the market. You can patent a drug and then still have several more years of development. So in practice, drugs are often on the market for less than their patent time. From the drug company’s perspective, they need to recoup their losses in that amount of time, and the high price of the name brand drug is funding the ongoing research of the next drug.

Generic drugs don’t have to go through animal or clinical trials, so companies making generic drugs ONLY have to consider the manufacturing cost when pricing their drugs. This is why they’re so much cheaper, because all they have to prove is that their drug is the same as the patented one.

Lenacapavir is STILL IN CLINICAL TRIALS, according to the source linked above. It hasn’t been approved for prevention. I believe it will probably be approved, but the point is that it’s a very new drug and still within its patent range. I’m not entirely sure when the patent was filed, but the fact is that it will have a generic eventually. Just not right now. But the reasoning for drugs being so expensive is that they’re factoring in the cost of research, not just the cost of production. I don’t like it! It’s a bad system! But that’s why it is the way it is

Source

[medsurfernews]

FDA Approves First Generic Once-Daily GLP-1 Injection for Type 2 Diabetes

The FDA has approved the first generic once-daily GLP-1 injection, liraglutide, to help lower blood sugar in patients with type 2 diabetes. This new generic option aims to improve patient access to affordable diabetes treatments. The U.S. Food and Drug Administration (FDA) has just approved the first generic version of a once-daily injection to help people with type 2 diabetes manage their blood…

[edwinscotte9947]

Glipizide & Metformin HCl Generic Metaglip

Glipizide and Metformin HCl, sold under the brand name Metaglip, is a combination medication used to manage Type 2 Diabetes. This powerful duo combines two oral antidiabetic agents, Glipizide (a sulfonylurea) and Metformin (a biguanide), providing enhanced glucose control by targeting insulin production and glucose absorption.

For those seeking affordable access to diabetes medications, DiRx offers Glipizide & Metformin HCl (Generic Metaglip) at competitive prices without the need for insurance. You can easily find and order this medication on DiRx's Glipizide & Metformin HCl page for cost-effective diabetes management.

How Does Glipizide & Metformin HCl Work?

This medication effectively controls blood sugar levels through a two-pronged approach:

Glipizide: Stimulates the pancreas to release more insulin, especially after meals, which helps lower blood sugar levels.

Metformin: Reduces glucose production by the liver and improves insulin sensitivity, allowing your body to use insulin more efficiently.

Together, these actions help control high blood sugar levels in people with Type 2 Diabetes, particularly when diet and exercise alone aren’t sufficient.

For individuals managing diabetes, DiRx provides this vital medication at an affordable cost, ensuring continued access to life-saving treatments.

Why Choose DiRx for Glipizide & Metformin HCl?

No Insurance Required: DiRx operates without the need for health insurance, offering savings directly to consumers.

FDA-Approved Medications: DiRx only sells FDA-approved drugs, ensuring safety and quality.

Affordable Prices: Get access to essential diabetes medications like Glipizide & Metformin HCl at significantly lower prices compared to retail pharmacies.

Visit DiRx to learn more about Glipizide & Metformin HCl and how you can save on your prescription needs.

[senritsu]

[mybestpharmacy]

Navigating the world of medications can be overwhelming, especially when faced with the choice between generic and brand-name drugs. At our pharmacy in Boynton Beach, Florida, we aim to provide clarity and guidance to help you make informed decisions about your health.

[gwiazdaerydanu]

The decline of science at the FDA has become unmanageable (from Livestre...

[emily-space]

What can we do about the soaring cost of prescription medicine?

Satish Srinivasan, CEO of DiRx, discusses the impact of soaring prescriptionmedicine costs and how DiRx is addressing this issue by offering affordablemedications directly from manufacturers and bypassing intermediaries. DiRx's modelhelps consumers save significantly on their prescriptions, making essential medicinesmore accessible to those in need.

[schizosupport]

Speaking of drugs, there's a new antipsychotic that has now been approved by the FDA, 'Cobenfy'. What's interesting about it is that its mechanism of action is completely different from any other existing antipsychotic since the 1950s where the 'current lineup' was born. It regulates acetylcholine (related to memory, learning and attention) and doesn't touch the dopaminergic system at all. In clinical trials it has proven an effective treatment for positive symptoms of psychosis at least on par with existing antipsychotics. A completely new mechanism of action gives hope to people who are treatment resistant and that's likely where it will be used most at first. But it is also going to have a very very different side effect profile, so for a lot of people this could prove more tolerable and helpful than the existing medications.

Now that it's going to start being prescribed, it will generate a lot of real world data. I'm daring to be cautiously optimistic.

[ms-demeanor]

I appreciate you starting a conversation about the harms of homeopathy, and I just want to mention that homeopathy/alternative medicine is also largely BS when it comes to treating our pets. A lot of essential oils and herbal remedies are toxic to cats and dogs even in small quantities, but people still try using them as flea and tick prevention because they don’t want to use “toxic” medicine that actually works. CBD isn’t FDA approved for dogs because it’s not been proven to be effective and safe, but a lot of folks have pushed me to try it for my dog because he’s on medication for extreme anxiety. Some folks will seek out animal chiropractors to “treat” their dog’s IVDD or hip dysplasia instead of pursuing pain management or surgical treatment. People think that vets look at their pets and see dollar signs instead of an animal needing treatment and turn to snake oil salesmen instead. It’s maddening.

Yeah that makes me fucking crazy.

@drferox and @why-animals-do-the-thing are great resources on tumblr who have spent a ton of time discussing animal woo in the past; both have slowed down on posting because life is hard and tumblr is tumblr, but both have done a lot of excellent writing about things like animal training, raw pet food, vaccination, and how to be a good human to your pets. If you've got questions about animals, search their archives and you're probably going to find a ton of useful information.

Folks, I swear veterinarians aren't coming for your wallets and they are generally criminally under-compensated for the work that they do. They're brilliant professionals who are driven by passion and fucked by the market.

Sorry i went to go find some studies on dogs and cbd and i ended up finding a reprint of a small study from the american holistic veterinary medical association and I found this on the pdf and i'm going to murder somebody

for those who are not aware young living is an essential oil mlm largely targeting mormon housewives that was started by a man whose child died being drowned at birth in an at-home-water-birthing incident and who himself likely died of cancer he tried to treat with essential oils.

This is one of those things that's like a big flashing neon sign that the study/journal you're looking at is a hot pile of bullshit.

Anyway. Yeah. Research supporting the safety and effectiveness of CBD on dogs is pretty thin on the ground. Your pets depend on you. The choices you make determine their health and wellbeing.

Listening to woo-peddlers who tell you not to vaccinate, or who hype up untested "healthy grain free diets," or who promote and sell cbd in absence of evidence of its effectiveness is putting your pets hands in the health of someone who doesn't care about your pet, they just care about profit.

Also, while I'm here: don't feed your dog grain free foods unless they have a diagnosed allergy, grain free foods can lead to liver and kidney problems, dogs are more omnivorous, not obligate carnivores like cats and grain is not bad for their diet nor unnatural for them to eat, and there are very few brands that have done decades of feeding tests on dogs (Royal Canin, Hills Science Diet, Pedigree, Eukanuba, and Iams) and none of them are Blue Buffalo.

Appeals to nature are extremely common in online woo discussions of pet food and vet care. Your dog is not a wolf and does not need to eat like a wolf. Your cat is not a lion and does not need to claim territory like a lion.

Vaccinate your pets, don't let them wander, feed them tested diets, and listen to your vet's advice on their care.

[zinniajones]

Text of thread at https://kolektiva.social/@zinnia/110418489814171631:

Yes - this is what is happening in Florida due to SB 254, which was signed into law on Tuesday 5/17/2023, taking immediate effect. This immediately cut off 80%+ of adult trans people in Florida from having their HRT refilled, because SB 254 uniquely prohibits only nurse practitioners from prescribing only gender-affirming medications.

This has already been in effect for 7 days now.

Trans adults in Florida have already been cut off from their HRT refills for a week now, including those of us who have been stable on these medications for years or decades.

This is VERY different from the general situation of trans youth care bans in 19 states, many still working their way through the courts.

This has *already* happened, to *all* of us: all trans adults in the third most populous state in the US.

The number of trans adults on HRT massively exceeds the sliver of the population that are under 18 and are prescribed puberty blockers or hormone therapy.

These laws, advanced under the pretext of 'protecting children', are now directly impacting a far larger group of people who are not children and are not subject to those pretextual concerns.

Other arguments about withholding public Medicaid funding for transition treatment also do not apply here: SB 254 does not even allow receiving this care through private insurance or paying cash out of pocket. The care isn't simply not covered - the care itself cannot be provided regardless.

What is happening in Florida requires special attention above the situation of trans youth care bans nationally. This is having a vastly larger impact quantifiably.

It will have worse impacts qualitatively as well: adults are responsible for taking care of and protecting trans kids and making sure they do not hurt themselves.

Whereas as a trans adult, we have no one standing guard at the brink but our own self and the void to which we are accountable.

These are the facts as they stand right now. These are the facts as they have stood for a WEEK and NO ONE nationally is putting any attention on this because there are 19 trans youth care bans all across the country going on, along with everything else targeting trans people and the LGBT community broadly.

This is a specific harm that is happening now and has been happening for 168 hours.

It is not a hypothetical issue to raise awareness of, as if it were at the stage of some proposal that needs to be fought back. This has already happened and is happening right now. Active harm is happening until this law is rolled back.

For all of Florida's history since the inception of the applicable regulatory and licensing bodies, nurse practitioners have been allowed to prescribe hormone therapy, testosterone blockers and other relevant gender-affirming medications.

That has been the case since I moved here in 2011. There was no reason why this wouldn't be the case. It's also the case in every other state.

This new law is a carveout of prescriptions when used for one purpose, gender-affirming care, from nurse practitioners specifically, in a way that has never been done before. It affects all ages.

It has immediately obstructed access to HRT prescription refills for more than 80% of TRANS ADULTS in Florida.

It has also prohibited first appointments for HRT via telehealth with in-state or out-of-state MDs or DOs - first appointments must be in person. This will require expensive and time-consuming travel that is beyond most trans people's means: driving to Georgia from Florida can take 8 hours.

This was an intentional targeting of almost all trans adults in Florida, and the means by which we have received our generic, FDA-approved medications for years. And it included closing every possible door that would let us find another way to keep taking the medications we have taken for...

Well, for me it was 3,891 days when the clock stopped

[swirlygigg]

i'm a scientist and i went to a talk where they discussed... basically psychosurgery for treating mental illness? putting probes in your brain that make electrical impulses. and those electrical impulses can help manage spikes of anxiety. you get a bluetooth controller for it to manage stuff yourself, but someone else ALSO gets the control--your therapist.

and genuinely, not joking, the tool that your therapist uses to help you with it is just called the master controller.

and to test if it's working? they stimulate it in a way that makes you smile involuntarily.

okay now imagine how i felt like listening to all of that. if you answered "way too horny" you were correct

EDIT:

wow i really need y'all to read up on science before you start making assumptions about stuff LMAO

(putting on a scientist hat) hi everyone. please read about Deep Brain Stimulation, which was approved by the FDA in 2009 and has has 400 surgeries since then with generally positive effects. it's largely cost-prohibitive despite its useful effects for people suffering from treatment-resistant mental illness and if someone wanted to do What You Are Assuming They Would Do then you are unaware of the way that medical treatment and research is currently developed and i think you could maybe look into that instead of fearmongering on a post clearly written on a HORNY BLOG!!!!



[dandelionsresilience]

Dandelion News - November 15-21

Like these weekly compilations? Tip me at $kaybarr1735 or check out my Dandelion Doodles! (sorry it's slightly late, the links didn't wanna work and I couldn't figure it out all day)

1. Wyoming's abortion ban has been overturned, including its ban on abortion medication

“Wyoming is the second state to have its near-total abortion ban overturned this month[…. Seven other states] also approved amendments protecting the right to an abortion. A lawsuit seeking to challenge the [FDA]’s approval of abortion medication recently failed when the Supreme Court refused to hear it[….]”

2. Patches of wildflowers in cities can be just as good for insects as natural meadows – study

“This study confirmed that small areas of urban wildflowers have a high concentration of pollinating insects, and are as valuable to many pollinators as larger areas of natural meadow that you would typically find rurally.”

3. Paris could offer new parents anti-pollution baby 'gift bags' to combat 'forever chemicals'

“The bag includes a stainless steel baby cup, a wooden toy, reusable cotton wipes, and non-toxic cleaning supplies as part of a "green prescription". […] The city will also have 44 centres for protecting mothers and infants that will be without any pollutants[….]”

4. Indigenous guardians embark on a sacred pact to protect the lowland tapir in Colombia

“The tapir is now the focus of an Indigenous-led conservation project[… A proposed “biocultural corridor”] will protect not only the populations and movements of wildlife such as tapirs, but also the cultural traditions and spirituality of the Inga and other neighboring Indigenous peoples[….]”

5. Denmark will plant 1 billion trees and convert 10% of farmland into forest

“[…] 43 billion kroner ($6.1 billion) have been earmarked to acquire land from farmers over the next two decades[.… In addition,] livestock farmers will be taxed for the greenhouse gases emitted by their cows, sheep and pigs from 2030, the first country to do so[….]”

6. The biggest grid storage project using old batteries is online in Texas

“[Element operates “used EV battery packs” with software that can] fine-tune commands at the cell level, instead of treating all the batteries as a monolithic whole. This enables the system to get more use out of each cell without stressing any so much that they break down[….]””

7. Durable supramolecular plastic is fully ocean-degradable and doesn't generate microplastics

“The new material is as strong as conventional plastics and biodegradable, [… and] is therefore expected to help reduce harmful microplastic pollution that accumulates in oceans and soil and eventually enters the food chain.”

8. Big Oil Tax Could Boost Global Loss and Damage Fund by 2000%

“[… A] tax on fossil fuel extraction, which would increase each year, combined with additional taxes on excess profits would […] generate hundreds of billions of dollars by the end of the decade to assist poor and vulnerable communities with the impact of the climate crisis[….]”

9. Rooftop solar meets 107.5 pct of South Australia’s demand, no emergency measures needed

“[T]he state was able to export around 658 MW of capacity to Victoria at the time[….] The export capacity is expected to increase significantly as the new transmission link to NSW[…] should be able to allow an extra 150 MW to be transferred in either direction by Christmas.”

10. Light-altering paint for greenhouses could help lengthen the fruit growing season in less sunny countries

“[Scientists] have developed a spray coating for greenhouses that could help UK farmers to produce more crops in the future using the same or less energy[… by optimising] the wavelength of light shining onto the plants, improving their growth and yield.”

November 8-14 news here | (all credit for images and written material can be found at the source linked; I don’t claim credit for anything but curating.)

[afeelgoodblog]

The Best News of Last Week - October 30, 2023

1. Bill to Ban Hidden Fees in California Signed into Law

California Attorney General Rob Bonta has released a statement regarding the signing of Senate Bill 478 (SB 478). SB 478, coauthored by Senators Bill Dodd and Nancy Skinner, will eliminate hidden fees, also known as 'junk fees,' in California starting from July 1, 2024. Hidden fees are deceptive charges that sellers include in transactions, either through obscured disclosures or later revelations, impacting consumers negatively.

2. New Portable Water Treatment System Vaporizes 99% of ‘Forever Chemicals’

A startup based Washington has devised a portable system capable of removing the vast majority of per- and polyfluoroalkyl substances, or PFAS, from water.

The system uses hydrothermal alkaline treatment, or HALT, to eliminate 99% of forever chemicals from water.

3. Tumor-destroying sound waves receive FDA approval for liver treatment in humans

The U.S. Food and Drug Administration has approved the use of sound waves to break down tumors—a technique called histotripsy—in humans for liver treatment. Technique developed at the University of Michigan provides a noninvasive alternative to surgery, chemotherapy and radiation treatments for cancer

4. Japan's top court says trans sterilisation requirement unconstitutional

Japan's Supreme Court has ruled that it is unconstitutional to require citizens to be sterilised before they can officially change genders.

The 2004 law said people could only change their gender if they have no reproductive capacity. Wednesday's ruling came after a transgender woman filed a petition challenging the law.

5. Abandoned golf courses are being reclaimed by nature

Golf courses, despite occupying large green spaces, are not necessarily good for the environment.

Conservation nonprofits and local authorities are looking to acquire golf courses that have been abandoned due to high maintenance costs, low player numbers or other reasons, and repurpose them into landscapes that boost biodiversity and build natural defenses against climate change.

6. NSW court allows health officials to give blood transfusion to Jehovah's Witness toddler

Regional New South Wales health officials have won a court order authorising them to give a blood transfusion to a Jehovah's Witness toddler if needed in surgery. The Supreme Court has been told the girl, three, who can only be referred to as JI, is in need of two surgical procedures. 

On such an application, the overriding criterion to be applied by the court is the best interests and welfare of the child.

7. North Atlantic right whale population has steadied, scientists say

The population of critically endangered North Atlantic right whales appears to have levelled off after a decade of steep decline, according to updated data released this morning by Canadian and American scientists. Scientists in the consortium said Monday that the 2021 estimate of 340 North Atlantic right whales in existence has been recalculated to 365 primarily because of the number of calves born that year.

The estimate for 2022 is 356.

---

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[macgyvermedical]

What's the history of gabapentin?

Gabapentin is a drug officially approved for partial seizures and posherpetic neuralgia (pain due to shingles).

It also represents the 10th most commonly prescribed drug in the US by number of prescriptions.

Now, that's not because that many people have epilepsy and shingles. Instead, it's because gabapentin is one of those drugs that you throw at the wall to see if it works. It is used off label for diabetic nerve pain, for anxiety, for restless leg syndrome, for alcohol (and methamphetamine, and cocaine) withdrawal, for a number of different acute and chronic pain syndromes, bipolar disorder, and migraines, and has probably been at least tried for everything else, too.

That is not to say that it actually works for everything. At most, it has about a 40% chance of being effective for things like diabetic neuropathy and anxiety, and it has a number of side effects that don't make it anywhere near a perfect drug. But if you notice, most of the things it's been tried and used for are usually treated with controlled substances. And in (most of) the US, gabapentin is not controlled. This makes it easier to prescribe and in theory that means it has less addiction/abuse risk than alternatives (only about 1% of people with an addiction history have used gabapentin recreationally).

Why gabapentin in particular? You may ask. Why not a first generation antipsychotic or a first generation antihistamine or a muscle relaxer? All of those are used as adjuncts to prevent having to prescribe controlled substances, right?

Well, that's because Pfizer broke the law. Repeatedly.

You may not know this, but if you're marketing a drug, you can only market it for what it has been approved by the FDA to treat. And Pfizer was going around telling anyone who would listen that their drug could be used for anything you didn't want to treat with a controlled substance. Which made it very attractive for prescribers and very lucrative for Pfizer.

But you know who really didn't like this situation? The insurance companies, which were paying a premium for this on-patent drug that at least according to the FDA was doing very little for things that weren't epilepsy or shingles.

So Kaiser (the insurance company) sued Pfizer and won a relatively paltry sum compared to the money Pfizer was making off of gabapentin, and Pfizer agreed to stop telling everyone that gabapentin could treat things the FDA said it couldn't. But since the cat was metaphorically out of the bag at that point, gabapentin continues to this day to be prescribed for everything.