Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has accepted Satsuma Pharmaceuticals’ 505(b)(2) new drug application (NDA) for STS101 for acute treatment of migraine, for review. The prescription drug user fee act (PDUFA) date is expected to be set as January 2024.

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pharmaphorum

NOVEMBER 1, 2021

Novartis has claimed FDA approval for one of its ‘wild card’ drugs – Scemblix – a first-in-class STAMP inhibitor for patients with previously-treated chronic myeloid leukaemia (CML). The post Novartis’ ‘wild card’ drug Scemblix gets FDA nod for leukaemia appeared first on.

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The FDA Law Blog

NOVEMBER 13, 2023

On January 23-24, 2024, the American Conference Institute (“ACI”) will host its “ Advanced Legal, Regulatory and Compliance Forum on OTC Drugs ” conference at the Sofitel New York, NY. FDA Law Blog readers can save 10% with the following promo code: D10-999-FDA24. Click here to view this year’s agenda and to register for the event.

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pharmaphorum

SEPTEMBER 30, 2022

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. The post Relief for Amylyx as FDA clears controversial ALS drug Relyvrio appeared first on.

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pharmaphorum

SEPTEMBER 20, 2021

Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’ Lucentis (ranibizumab) for leading causes of blindness, raising the prospect of a cheaper treatment option for US patients. The post FDA OKs first biosimilar of Roche’s blockbuster AMD drug Lucentis appeared first on.

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Pharmaceutical Technology

APRIL 21, 2023

On 14 April, the FDA rejected Lilly’s biologic licence application (BLA) for their anti-interleukin (IL)-23, mirikizumab, which is in development for the treatment of ulcerative colitis (UC). The recent setback dents mirikizumab’s chances to be the first among the IL-23 inhibitors to launch in the US for UC.

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European Pharmaceutical Review

NOVEMBER 28, 2023

The US Food and Drug Administration (FDA) has approved the first drug for desmoid tumours (desmoid fibromatosis), an oral gamma secretase inhibitor. The FDA’s approval of Ogsiveo is based on results from the Phase III DeFi clinical trial , which were published this year in the New England Journal of Medicine.

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Labelling FDA 83

The Checkup by Singlecare

APRIL 10, 2024

The Food and Drug Administration (FDA) first reported the shortage in December 2022, but availability issues have continued long after that. In fact, as recently as April 2, 2024, the FDA announced that shortages of certain Mounjaro dosages were expected to continue at least through the end of April.

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The FDA Law Blog

MARCH 29, 2023

Richardson — Early on March 29, 2023, FDA announced the landmark approval of Narcan (naloxone hydrochloride) Nasal Spray for use as a nonprescription opioid overdose reversal agent. FDA Commissioner Robert M. According to this announcement, FDA approval of RiVive is anticipated in July 2023 and the U.S. By Kalie E. Califf, M.D.

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The Checkup by Singlecare

MARCH 25, 2024

Unlike Ozempic, which is FDA approved to treat Type 2 diabetes, Wegovy is approved for weight loss in patients with a body mass index (BMI) of 30 or higher and in patients with a BMI of 27 or higher who also have a weight-related medical condition like Type 2 diabetes, high blood pressure, or high cholesterol.

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Pharmaceutical Technology

JUNE 21, 2023

Ketarx will be marketed under the FDA-approved label of ketamine and in dosages that include 10mg/ml, 50mg/ml and 100mg/ml, with the option to boost the concentration and ready-to-administer applications. Ketamine is currently on the FDA’s drug shortage list. Ketarx will then be commercially launched in the second quarter.

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The FDA Law Blog

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. However, FDA’s legal standing to insist on cybersecurity features, especially within the substantial equivalence paradigm, has been questionable. Loose Ends IDEs.

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The FDA Law Blog

OCTOBER 24, 2022

355g(a), directed FDA to “establish a program to evaluate the potential use of real world evidence” both “to help to support the approval of a new indication” and “to help to support or satisfy postapproval study requirements.” The sponsor and FDA reach agreement on the study design information to be publicly disclosed.

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The Checkup by Singlecare

MAY 5, 2024

Food and Drug Administration (FDA) for the treatment of ADHD symptoms. In addition to uses for ADHD, Vyvanse is FDA-approved for binge eating disorder in adults. Strattera is occasionally prescribed off-label for cataplexy and orthostatic hypotension. on the label. The incidence of this adverse effect is listed as 0.4%

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The Checkup by Singlecare

MARCH 7, 2024

Yet the Food and Drug Administration (FDA) hasn’t approved this GLP-1 agonist injection for weight loss. Instead, it’s FDA approved to improve glycemic control in adults with Type 2 diabetes and to reduce the risk of adverse cardiovascular events in adults with Type 2 diabetes and known heart disease.

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European Pharmaceutical Review

NOVEMBER 25, 2022

GlobalData’s report showed LY03010 is expected to launch in the US in 2024. According to the pre-IND meeting with the US Food and Drug Administration (FDA), Luye Pharma plans to submit the New Drug Application (NDA) for LY03010 to the FDA through the 505(b)(2) pathway. If successful, the drug is forecasted to reach sales of $63.5

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The FDA Law Blog

DECEMBER 12, 2023

We know what you must be thinking: “With all this crystal formation, why don’t they call them Glitter boxes?” (Apologies to our readers—word play is FDA Law Blog’s catnip.) You can submit comments on the draft guidance here until February 28, 2024—unless, of course, the cat’s got your tongue.

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European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics. cited 2024Mar].

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European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics. cited 2024Mar].

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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. Novartis will have to wait for the results of the ORION-4 study – due in 2024 – before it has a chance of matching the labels of Amgen and Sanofi/Regeneron’s drugs.

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pharmaphorum

OCTOBER 19, 2020

Both Repatha and Praluent have that in hand, but Novartis will have to wait for the results of the ORION-4 study – due in 2024 – before it has a chance of matching the labels of Amgen and Sanofi/Regeneron’s drugs. That said, Novartis is no stranger to building a slow-starting cardiovascular drug into a blockbuster franchise.

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Pharmaceutical Technology

JUNE 16, 2023

Earlier this month, the US Food and Drug Administration (FDA) approved the drug’s investigational new drug application (IND) to start this trial. The company aims to run an interim analysis of the trial by mid-2024 at the very latest. Buntinx added that the study will enrol up to 600 patients across Europe, South America, and the US.

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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

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The Checkup by Singlecare

MARCH 1, 2024

Food and Drug Administration (FDA) classifies it as a category C drug , meaning animal studies have found adverse effects on the fetus. But that’s an off-label use, and while it might help to quell overthinking momentarily, the boost in norepinephrine could exacerbate anxiety symptoms.

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The Checkup by Singlecare

APRIL 2, 2024

Food and Drug Administration (FDA) to treat obesity in the short term and is meant to be combined with exercise, calorie reduction, and behavioral modifications. RELATED: Overweight and obesity statistics 2024 Where can I get phentermine? The FDA offers tips on how to choose a legitimate online pharmacy.

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pharmaphorum

DECEMBER 5, 2022

The positive news comes after a challenging time for GSK, marked by the withdrawal of its US marketing approval for multiple myeloma therapy Blenrep (belantamab mafodotin) last month, along with the narrowing of the label for PARP inhibitor Zejula (niraparib), as well as a retreat from the cell therapy category.

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pharmaphorum

OCTOBER 19, 2020

Both Repatha and Praluent have that in hand, but Novartis will have to wait for the results of the ORION-4 study – due in 2024 – before it has a chance of matching the labels of Amgen and Sanofi/Regeneron’s drugs. That said, Novartis is no stranger to building a slow-starting cardiovascular drug into a blockbuster franchise.

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Labelling FDA 52

Pharmaceutical Technology

JANUARY 10, 2023

In addition, market growth will be driven by dapagliflozin (Farxiga) in the SGLT-2I space, and novel GLP-1/GIP Mounjaro (tirzepatide), biosimilar/interchangeable insulins such as insulin lispro and insulin glargine (Basaglar), and the launch of once-weekly insulins icodec and Icosema, forecast for 2024 launch.

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European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. Ophthalmic drug products should be evaluated for extractables and leachables, FDA asserted.

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The Checkup by Singlecare

DECEMBER 5, 2023

Levothyroxine (a thyroid hormone) is FDA approved to treat hypothyroidism , a condition in which the body produces less thyroid hormone than your body needs. It’s FDA approved to treat attention-deficit/hyperactivity disorder (ADHD) symptoms, including inattention, hyperactivity, and impulsivity. Approximately 1.2% Stay tuned!

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The FDA Law Blog

FEBRUARY 28, 2024

This is the third withdrawal of an accelerated approval FDA has performed, following Avastin in 2011 and Makena in 2023. Without commenting on the merits of the decision, it is an interesting window into how FDA may use these new procedures in practice. Tobolowsky & Michelle L.

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The FDA Law Blog

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. HHS forwards FDA’s analysis and recommendation to DEA. By Larry K.

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The FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year.

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The Checkup by Singlecare

MARCH 21, 2024

Nonetheless, healthcare providers may prescribe it off-label for weight loss. Its active ingredient, semaglutide, is FDA approved for weight loss under the brand name Wegovy , which has a dosing progression of 0.25 has said they expect the shortage to last at least until March 2024. mg, 1 mg, 1.7 mg, and 2.4

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The FDA Law Blog

JUNE 16, 2023

Initial appointments to both the Board and advisory council will occur by January 1, 2024. Prescription Drug Affordability Board The law also establishes a nine-member Prescription Drug Affordability Board and an 18-member stakeholder advisory council to provide advice to the Board on drug cost issues.

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The Checkup by Singlecare

FEBRUARY 16, 2024

Food and Drug Administration (FDA). Atrovent HFA is an asthma inhaler that contains ipratropium and is used for chronic obstructive pulmonary disease (COPD) but is also used off-label (for a non-FDA-approved use) for quick relief of asthma attacks. It is expected to be available sometime in 2024.

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The FDA Law Blog

OCTOBER 6, 2023

Javitt & Philip Won — As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests (LDTs). The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. By Allyson B. Mullen & Gail H.

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