PharmTech

JUNE 6, 2025

2022 11, 41-44 Greer, F and Easton, R.L. Eisai Wins Judgment Against Shilpa Over Sale of Lenvatinib Mesylate Generic Patrick Lavery June 2nd 2025 Article As a result of the decision, Shilpa will not be eligible to receive FDA approval for its lenvatinib mesylate generic until February 2036. Specifications. Easton, R.L.

Dosage

The Checkup by Singlecare

AUGUST 7, 2025

Another generic version of Symbicort, Breyna , was approved by the FDA for production by a different manufacturer (Viatris) in March 2022. To be FDA-approved, generic drugs have to contain the same active ingredient(s) as their brand-name counterparts, and they have to be just as safe and effective. mcg/act or 160/4.5

Insurance

The Checkup by Singlecare

JUNE 25, 2025

Due to Ozempic’s newsworthy shortages and a growing demand for more GLP-1 drugs, people started talking about Mounjaro in 2022, when it was approved by the Food and Drug Administration (FDA) for the treatment of Type 2 diabetes. Mounjaro was approved by the FDA in 2022 for the treatment of Type 2 diabetes.

Insurance

Pharmacy Times

JUNE 23, 2025

The Orange Book is the reference, and it allows the FDA to declare something [to be] therapeutically equivalent. The FDA Approval Process Within the FDA approval process, the 505(b)(1) new drug application (NDA) submission pathway is the pathway by which new drugs are able to seek approval.

FDA

PharmTech

JULY 4, 2025

While treatments for infection, inflammation, high eye pressure, and neovascularization have been shown to be effective, this method of delivery is considered “off-label,” as FDA has not approved products specifically for this use, except two intracameral implants (see below). In addition, many patients are hesitant to receive eye injections.

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Pharmacy Times

JUNE 9, 2025

FDA approval of LIMITX for broader use could significantly impact opioid misuse prevention and save lives. Or, as FDA officials like to call it, “multiple tablet ingestion”—I guess it sounds better to them. September 28, 2022. SHOW MORE A novel solution can strategically control the release of the drug in vivo. REFERENCES 1.

Compounding Pharmacies

Pharmacy Times

JUNE 19, 2025

2-4 In the United States, the FDA had approved 44 cell therapy products as of March 6, 2025. In October 2024, CAR T therapy axicabtagene ciloleucel (Yescarta; Kite Pharma) received FDA regenerative medicine advanced therapy designation as a first-line treatment for high-risk large B-cell lymphoma. Accessed February 2025. March 6, 2025.

Compounding

PharmTech

JUNE 12, 2025

Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS). American Behavioral Research Institute Boca Raton, Fla. –

FDA

The Checkup by Singlecare

NOVEMBER 4, 2024

Made with the same active ingredient as Ozempic , semaglutide, Wegovy is approved by the Food and Drug Administration (FDA) for weight management in adults and adolescents 12 years and older with obesity and adults who are overweight with a weight-related health condition, such as high blood pressure or diabetes. The starting dosage of 0.25

Dosage

The Checkup by Singlecare

MAY 6, 2025

As a prescription opioid, it has different approved uses based on the dosage form: Injectable fentanyl is used as a pain reliever during or after surgery or as an add-on to general or local anesthesia. Fentanyl may also be prescribed off-label, meaning for a purpose other than what the Food and Drug Administration (FDA) approved it for.

Labelling

PharmTech

JUNE 24, 2025

In May 2024, the US Food and Drug Administration (FDA) approved Moderna’s next-generation base-modified mRNA-lipid nanoparticle (LNP) respiratory syncytial virus (RSV) vaccine mRESVIA (mRNA-1345) in adults aged 60 years and older with lower respiratory tract disease (5). falciparum malaria.

Vaccines

The Checkup by Singlecare

JULY 8, 2025

2017) In 2022 alone, there were an estimated 534,890 people in the U.S. using Linzess ( ClinCalc , 2022) By 2024, more than 5 million people had been prescribed Linzess since its approval. 2025) From 2022 to 2023, Linzess saw an increase in prescription demand of 10%. million unique patients. Ironwood Pharmaceutical Inc.

Insurance

PharmTech

JUNE 12, 2025

Recent Videos Related Content FDA Posts Slate of Seven Warning Letters Following Company Inspections Patrick Lavery June 12th 2025 Article The warning letters deal with a range of violations involving items from personal hygienic products to mismarketed analgesics. billion (1). billion (1). billion (1). June 12, 2025.

Dosage

The Thyroid Pharmacist

AUGUST 1, 2025

Women with treated thyroid conditions will likely need to adjust their medication dosage, perhaps multiple times. One 2022 study even suggests that a third of women who deliver via C-section may experience delayed lactogenesis II. [40] Updated 2022 Jul 25]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-.

Health and Personal Care Stores

The Checkup by Singlecare

JUNE 6, 2025

Although the Food and Drug Administration (FDA) has approved them for different uses, they’re commonly used as weight loss drugs. Note that compounded semaglutide and compounded tirzepatide products are not FDA approved.) While these drugs are commonly prescribed for weight loss, they do not have the exact same FDA-approved uses.

Insurance

The Checkup by Singlecare

MARCH 10, 2025

The medication is available in both brand-name and compounded forms, although the compounded forms are not FDA approved. Some insurance plans may cover Ozempic for managing Type 2 diabetes , which is an indication that is approved by the Food and Drug Administration (FDA) to treat. Does insurance cover Ozempic? affected by a shortage).

Compounding

PharmTech

JULY 11, 2025

Unprecedented Move Previously, the FDA had not routinely shared CRLs publicly. A 2015 cross-sectional study published in BMJ found that drug developers omitted around 85% of safety and efficacy concerns noted by the FDA in their public statements (2). Sponsors often disclosed minimal information when announcing a non-approval.

FDA

The Checkup by Singlecare

JUNE 6, 2025

However, the Food and Drug Administration (FDA) has approved Ozempic for additional indications that Mounjaro hasn’t been approved for. While Mounjaro and Ozempic have some similarities, they are not exactly the same, especially when it comes to weight loss, which is an indication that’s not approved by the FDA but is a common off-label use.

Insurance

PharmTech

JULY 14, 2025

2022 23:13–19. 2022 23:21–29. 2022 23:65–71. Recent Videos Related Content FDA Publishes More Than 200 Complete Response Letters Christopher Cole July 11th 2025 Article FDA says the move boosts regulatory transparency, offering insights into common approval barriers in drug applications and reducing guesswork.

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STAT

JULY 18, 2025

The FDA is set to decide whether to approve the drug, called Blenrep, as soon as next week. market in 2022 after failing a late-stage study. GSK was trying to revive the drug, which was pulled from the U.S.

Dosage

The Checkup by Singlecare

DECEMBER 8, 2022

Here’s a look at the 50 most-filled prescriptions of 2022. 50 most prescribed drugs of 2022. 1, 2022 through Oct. 31, 2022, excluding opioids and weight-loss drugs. Read on to learn more about the top 10 drugs of 2022. . Dosage | Side effects. Dosage | Side effects. Dosage | Side effects.

Dosage

The Checkup by Singlecare

OCTOBER 30, 2023

Food and Drug Administration (FDA) approved Zituvio (sitagliptin) for adults with Type 2 diabetes. This approval is noteworthy because in 2022 the FDA found nitrosamine impurities in certain samples of sitagliptin , raising concerns about potential shortages of these two drugs. What is Zituvio (sitagliptin)?

FDA

Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. The FDA nod means Rinvoq is now approved for seven indications in gastroenterology, rheumatology and dermatology.

Mayo Clinic

The Checkup by Singlecare

MAY 1, 2025

Food and Drug Administration (FDA) in 2010. In 2022, it was the 139th most prescribed drug. Since 2010, Victoza has had more FDA approvals, including one in 2019, where it was approved for pediatric patients with type 2 diabetes. When the FDA approved the generic version of Victoza, Iilun Murphy, M.D., milligrams daily.

Dosage

The Checkup by Singlecare

FEBRUARY 10, 2025

Januvia, a brand name for sitagliptin, is a commonly prescribed drug for Type 2 diabetes, with almost 8 million total prescriptions reported in 2022. Food and Drug Administration (FDA) approved Januvia in 2006. Despite these differences, both must meet the same quality and safety standards the FDA sets.

Dosage

Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. The post Can the FDA keep the momentum going for rare disease drug approvals?

FDA

The Checkup by Singlecare

DECEMBER 7, 2022

Read on to learn more about most popular prescription drugs by city in the 50 largest cities in the country in 2022. . Food and Drug Administration (FDA) recently announced a shortage of amoxicillin. . The FDA recently declared a shortage of some immediate-release formulations of Adderall. 1, 2022 through Oct. Lisinopril.

FDA

The Checkup by Singlecare

FEBRUARY 8, 2024

Zyrtec was approved by the United States Food and Drug Administration (FDA) in 1995. The first generic of prescription Zyrtec, cetirizine, was approved by the FDA in 2008, around the time the medication became available over the counter. The brand-name and generic products contain the same ingredients and dosage.

Dosage

The Checkup by Singlecare

AUGUST 5, 2023

Initially approved by the FDA in 1996 for ADHD, Adderall has since become a widely prescribed medication in the United States. As there is currently a drug shortages of Adderall in the United States, which has been ongoing since October of 2022, more healthcare providers may prescribe the generic alternative.

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pharmaphorum

JUNE 6, 2021

Novo Nordisk is celebrating the FDA approval of its GLP-1 agonist semaglutide as a treatment for obesity, which it believes has the potential to redefine the market for weight-loss medicines. . The post FDA ends 7-year obesity drug drought, clearing Novo Nordisk’s Wegovy appeared first on. Photo by i yunmai on Unsplash.

FDA

The Checkup by Singlecare

FEBRUARY 14, 2024

That’s why even though the medication is only approved by the Food and Drug Administration (FDA) for Type 2 diabetes, it’s also used off-label as a weight-loss medication. A 2022 SURMOUNT-1 trial published in the New England Journal of Medicine examined the effects of tirzepatide on patients with obesity. of their body weight.

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European Pharmaceutical Review

JUNE 28, 2023

The clinical trial will combine dosages of a new psilocin-based drug with specialist therapy. The MHRA’s regulatory decision comes after Mindset Pharma, along with several other psychedelic drug developers, agreed In December 2022 to trial therapies for mental health conditions in London.

Dosage

The Checkup by Singlecare

DECEMBER 5, 2023

Prescriptions for Ozempic and other glucagon-like peptide-1 (GLP-1) medications—like Mounjaro , Trulicity , and Rybelsus —skyrocketed at the end of 2022 and into 2023. Food and Drug Administration (FDA) recently approved Zepbound , a new version of Mounjaro, for weight loss. Where is Ozempic most popular?

Insurance

The Checkup by Singlecare

MARCH 21, 2024

Ozempic dosage and administration Ozempic (semaglutide) is an injectable medication from a class of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists , which tell the pancreas to release insulin when blood sugar levels get too high. It comes in single-patient-use pens of various dosages, which patients inject once a week at home.

Insurance Coverage

pharmaphorum

JANUARY 23, 2023

Beijing-based pharma, BeiGene’s Brukinsa (zanubrutinib) has been approved by the US Food and Drug Administration (FDA) for chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL). The post BeiGene’s Brukinsa FDA approved for CLL/SLL appeared first on. of patients.

FDA

The Checkup by Singlecare

JANUARY 13, 2025

Mounjaro was approved by the Food and Drug Administration in May of 2022 to help manage Type 2 diabetes. Subcutaneous injection as a single-dose pen or vial Subcutaneous injection as a single-dose pen or vial What is the standard dosage? Then, the dosage is increased to 5 mg once weekly. The dosage may be increased in 2.5

Insurance

The Checkup by Singlecare

NOVEMBER 19, 2024

Amoxicillin is approved by the Food and Drug Administration (FDA) to treat bacterial infections affecting the nose, ear, and throat, as well as lower respiratory tract infections, sinus infections, ulcers, and skin infections. Amoxicillin is a type of penicillin antibiotic used to treat various bacterial infections.

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