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Amid ongoing concern over the quality of medicines made in India, a major supplier of genericmedicines was seen removing three truckloads of “scrap materials” from a facility that was being inspected last month by the Food and Drug Administration.
In explaining its new policy statement , the FTC noted that some drug companies have failed to follow requirements for listing patents in the so-called Orange Book in hopes of thwarting competition from lower-cost genericmedicines.
The review comes in response to an inspection of Synapse facilities by Spanish regulators, who raised “serious concerns about the validity and reliability” of clinical trial data generated by the company.
The US Food and Drug Administration (FDA) has announced that it has approved several first generics of Takeda’s Vyvanse (lisdexamfetamine dimesylate) capsules and chewable tablets for attention-deficit/hyperactivity disorder (ADHD) in patients over the age of six years and for moderate-to-severe binge-eating disorder (BED) in adult patients.
The FDA approval of Alkermes’ new antipsychotic drug Lybalvi couldn’t have gone any better for the company, but it could still face a big challenge positioning the new drug in the highly genericised market. The post After FDA approval, Alkermes plans soft launch for antipsychotic Lybalvi appeared first on.
It looks like Astellas has been unsuccessful in its attempt to block Pfizer’s genericmedicines unit Hospira from launching a copycat version of big-selling pharmacologic stress agent Lexiscan in the US. Hospira isn’t the only generics company trying to bring a version of regadenoson to the US market.
Astellas has won a reprieve in its attempt to stop Pfizer’s genericmedicines unit Hospira launching a copycat version of its pharmacologic stress agent Lexiscan in the US – but only for a couple of weeks. ” Hospira isn’t the only generics company trying to bring a version of regadenoson to the US market.
This combination inhaler is also available as a genericmedicine called fluticasone furoate and vilanterol , which are the names of the two medicines in the inhaler. Some maintenance treatments for asthma are only FDA -approved in certain ages, limiting use in children. RELATED: COPD vs. asthma: Which is worse?
Food Drug Administration (FDA) , a genericmedicine works in the same way and provides the same clinical benefit as brand-name medicine. Generic medications must have the same dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. How much is generic Zoloft?
Food and Drug Administration ( FDA ) in 2014 for Type 2 diabetes. Since then, its FDA -approved uses have expanded, now including kidney disease, heart failure , and Type 2 diabetes. As of 2024, Prasco has offered an authorized generic version of dapagliflozin (more on authorized generics below).
Lexapro was approved by the United States Food and Drug Administration (FDA) in 2002. A Lexapro generic, called escitalopram, has been available since 2012. Continue reading to learn more about Lexapro and its generic escitalopram. What are the differences between brand name and generic Lexapro? In 2020, an estimated 6.3
Abilify first received FDA approval in 2002. Although Abilify is well known by its brand name, an Abilify generic is available. The generic name of Abilify is aripiprazole, commonly prescribed for mental health conditions. Aripiprazole was approved by the FDA in 2015. mL, 960 mg/3.2
Food and Drug Administration (FDA) as an adjunct to be used along with an antidepressant medicine to treat major depressive disorder (MDD) in adults. It is also FDA-approved to treat schizophrenia in adults and children ages 13 and older and to treat agitation that may occur with dementia due to Alzheimer’s disease.
Xigduo XR is a brand-name prescription medication approved by the Food and Drug Administration (FDA) for managing Type 2 diabetes in adults and children 10 years and older. Sometimes, there are genericmedicines or other treatment plans that can effectively manage your condition at a lower cost.
Yes, there is a generic version of Cialis available called tadalafil. Generic Cialis became available in the United States after the exclusivity patent for Cialis , held by Eli Lilly, expired in 2018. As a genericmedicine, tadalafil offers the same benefits and uses as Cialis but typically at a lower price.
Food and Drug Administration (FDA). It’s usually dispensed in pharmacies as a genericmedicine, but healthcare providers commonly refer to it by brand names Flexeril (immediate-release tablets), Fexmid (immediate-release tablets), or Amrix (extended-release capsules). Flexeril is no longer made in the U.S.
Savella is FDA-approved to treat fibromyalgia (a chronic pain condition) and can be used off-label for depression. Lyrica (pregabalin) Lyrica is an anti-seizure medication also available as a genericmedicine called pregabalin. Effexor: Differences, similarities, and which is better for you 2.
The pharmaceutical industry is no different, with India and China becoming two of the leading manufacturers and exporters of genericmedicine, as well as medical supplies, antibiotics and ingredients required to manufacture treatments. By its own figures, the agency managed 61% of the planned inspections it had scheduled for 2020.
As with other drugs, some patients may believe that branded medicine is better than generic medication. Genericmedicines are usually much cheaper because they do not go through the same process of marketing authorisation. Questions and answers on genericmedicines. FDA (2021). Ann Pharmacother.
Last week, the US FDA approved a new gene therapy for eligible adults with haemophilia B. The committee also recommended the biosimilar medicine Wezenla (ustekinumab) to treat of plaque psoriasis. Genericmedicine Eribulin Baxter (eribulin) was also granted a positive opinion by the committee, to treat breast cancer and liposarcoma.
Moreover, more than any other medicine, antibiotics are more likely to face insufficient supply, with analysis by the US Pharmacopeia suggesting they are 42% more likely to be in shortage compared to all other drugs. Larger questions remain around the way in which to support manufacturers to invest in production capabilities for antibiotics.
Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. These medicines comprise about 10% of all generics approved each year. Still, the FDA does prioritize the review of submissions for first generics.
Despite policies, guidelines, and regulations to promote the diversification of clinical trial groups by the European Medicines Agency (EMA) and FDA, the inclusion of key demographic populations within clinical research continues to be less than proportionate to their representation in society.
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