Search Results for “FDA” – Page 49 – media

FDA approves ANDA of 20mg generic Nitisinone capsules

Nitisinone capsules are indicated for patients with hereditary tyrosinemia type 1 in combination with dietary restriction of tyrosine and phenylalanine Analog Pharma and Dipharma have announced that the US Food and Drug Administration (FDA) has approved their 20mg nitisinone capsules, a generic equivalent of Swedish Orphan Biovitrum’s Orfadin. Analog already distributed the 2mg, 5mg and 10mg doses. Nitisinone capsules are used in the treatment of adult and paediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Tanya Carro, executive vice president of Analog Pharma, commented: “With the approval of the 20mg capsule, we now have a full complement of room temperature stable strengths for our generic Nitisinone. Considering that the 20mg is the most commonly prescribed strength of Orfadin, this will bring American patients with HT-1 a room temperature-stable treatment option. The addition of this new dosage form to our portfolio demonstrates ...
- Source: drugdu
- 110
- June 5, 2023
FDA hits iRhythm with warning letter over problems at heart monitor facility

Dive Brief The U.S. Food and Drug Administration has issued a warning letter to iRhythm Technologies after inspectors found fault with practices at a facility that makes its heart monitors. According to iRhythm, the FDA has alleged “nonconformities to regulations for medical devices, including medical device reporting requirements, relating to the company’s Zio AT System and medical device quality system requirements.” iRhythm can continue to manufacture and sell its products and does not expect the warning letter to materially affect its financial results. However, the situation comes at a time when iRhythm is working to continue the recent recovery of sales of Zio AT. Dive Insight FDA inspectors concluded their assessment of iRhythm’s facility in Cypress, Calif. in August 2022. The FDA visit led to a Form 483 later that month. iRhythm took steps to address the concerns raised in the 483 but its actions failed to stop the FDA ...
- Source: drugdu
- 134
- June 4, 2023
AZ, Merck’s Lynparza wins FDA nod in prostate cancer subgroup following advisory committee vote

After a panel of independent experts endorsed a narrow approval for AstraZeneca and Merck’s Lynparza in metastatic castration-resistant prostate cancer (mCRPC), the FDA has followed suit.Lynparza can now be used in combination with Johnson & Johnson’s Zytiga and a corticosteroid to treat patients with mCRPC whose tumors have BRCA mutations. The approval limits Lynparza’s use in the mCRPC population to about 10% of patients. The FDA’s decision comes after agency staffers and a committee of outside experts argued that the drug only showed a favorable risk-benefit in that population. Results from the phase 3 PROpel trial showed that the combo cut the risk of disease progression or death by 34% compared with solo Zytiga in newly diagnosed mCRPC patients regardless of mutation status. However, the FDA noted a “significant design flaw” with the trial in its briefing documents ahead of the meeting. Specifically, the FDA argued that the study didn’t ...
- Source: drugdu
- 146
- June 3, 2023
FDA warns patients about compounded versions of Novo Nordisk’s Ozempic, Wegovy

In the rush to supply prescriptions of Novo Nordisk’s popular diabetes and weight loss meds, some pharmacies are making unauthorized versions of Ozempic and Wegovy, the FDA warned on Tuesday. Some compounding pharmacies, which are permitted to make drugs during times of shortage, are using unauthorized versions of semaglutide—the key active ingredient in the GLP-1 drugs. Compounding pharmacies are currently allowed to make Ozempic and Wegovy because they are in short supply. But they must use approved ingredients, the FDA points out. The agency has received adverse event reports after patients have used compounded semaglutide. In some cases, compounders may be using salt forms of semaglutide, called semaglutide sodium or semaglutide acetate, which have not been proven to be safe or effective. The FDA asks users of Ozempic and Wegovy to get a prescription from a licensed provider and only obtain drugs from state-licensed pharmacies or outsourcing facilities registered with ...
- Source: drugdu
- 174
- June 2, 2023
FDA warns about compounded semaglutide-based drugs

Tyler Patchen The FDA has warned the public that compounded versions of popular GLP-1 drugs Ozempic and Wegovy may not include the same ingredients as the prescription medications, and that has raised questions about their safety and effectiveness. The regulator said Tuesday it has received reports of adverse events related to compounded versions of semaglutide, the active ingredient in Ozempic and Wegovy. Some products being marketed as semaglutide contain the salt formation of semaglutide, which is not considered safe or effective. Novo Nordisk’s Ozempic and Wegovy, both of which contain semaglutide, are approved to treat type 2 diabetes and obesity, and demand for the drugs has soared over the last two years, given the ability of both therapies to help people lose weight. That demand has created a supply crunch, with both medications on the FDA’s shortages list. Though compounding medications is legal when drug shortages occur, the compounded versions ...
- Source: drugdu
- 121
- June 2, 2023
FDA’s cancer chief weighs in on common chemo shortages — report

Tyler Patchen Richard Pazdur, director of the FDA’s Oncology Center of Excellence, attributes the current shortage of two cancer drugs to drug companies that haven’t invested in building out their production capacity. In an interview with The Cancer Letter, a weekly cancer publication, Pazdur said that the current shortages of cisplatin and carboplatin, a pair of drugs used to treat a wide range of cancer patients, are the result of two problems: manufacturers not investing in enhancing production capacity, and drug companies being dependent on one supplier of raw ingredients. The cisplatin shortage followed an inspection that revealed quality issues at a manufacturing facility, which then led to the shutdown of production. This led to a surge in carboplatin demand, creating a secondary shortage. The shortages are causing oncologists across the US to ration platinum-based drugs, according to The Cancer Letter. To restore the supply of cisplatin, the FDA is ...
- Source: drugdu
- 122
- June 2, 2023
FDA decisions that could be delayed if the U.S. defaults on its debt

As lawmakers trudge through debt ceiling negotiations, the possibility that the U.S. will default on its loan obligations in the coming days looms like a dark cloud over Washington. Should government coffers run dry on June 1, as Treasury Secretary Janet Yellen has warned they could, federal workers will go unpaid and agencies like the FDA could see operations come to a screeching halt. Just last week, FDA Commissioner Robert Califf said that without a bipartisan bill to raise the debt limit by June, the regulator wouldn’t have the money to pay staff and scientific reviewers, potentially delaying upcoming drug approval decisions, advisory committee meetings and regulations. And with President Joe Biden and House Speaker Kevin McCarthy scrambling to finish negotiations — while haggling over where to cut federal spending in future budget packages — it’s unclear when a deal might be struck, or how long a potential default could ...
- Source: drugdu
- 127
- May 31, 2023
What is the process for obtaining FDA certification in the United States?

Drugdu.com expert’s response: 1.Pre-Submission Consultation: This initial step often involves a formal or informal consultation with the FDA to discuss the product’s classification, the type of application needed, and data requirements. 2.Preparing Documentation: Following consultation, you’ll need to prepare all necessary documentation, which usually includes preclinical and clinical data, product information, manufacturing details, labeling, and more. The exact documentation needed will depend on the product classification and type of application. 3.Submission of Application: The next step is to submit your application or registration to the FDA. The type of application may include a Premarket Notification (510(k)), Premarket Approval (PMA), Investigational Device Exemption (IDE), or others, based on the product classification. 4.FDA Review: Once the FDA receives your application, they will conduct a review. This involves an assessment of all submitted materials and may include inspections, additional data requests, and more. 5.FDA Decision: After the review process, ...
- Source: drugdu
- 312
- May 30, 2023
Pfizer’s Paxlovid approved by FDA and Gilead’s Veklury recommended by CHMP

Pfizer’s Paxlovid (nirmatrelvir and ritonavir tablets) has been approved by the US Food and Drug Administration (FDA), and Gilead Science’s Veklury (remdesivir) recommended by the European Medicines Agency’s human medicines committee to treat certain COVID-19 patients. Pfizer’s oral antiviral, which has now been granted full approval to treat mild-to-moderate COVID-19 in adults at a high risk for progression to severe disease, has been available in the US since December 2021 under the FDA’s accelerated approval pathway. The agency’s latest decision is supported by the totality of evidence submitted by Pfizer, the company said, including efficacy data from the phase 2/3 EPIC-HR study showing an 86% reduction in risk of COVID-19-related hospitalisation or death from any cause in patients who took Paxlovid within five days of symptom onset. The drugmaker said in a statement that at this time, the US government will continue to oversee the distribution of Paxlovid, and eligible ...
- Source: drugdu
- 107
- May 30, 2023
FDA approves Lexicon’s heart-failure drug after defeat in diabetes

Nicole DeFeudis Editor The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi. The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday. The company did not release Inpefa’s price but said it will be “comparable to existing branded heart failure medications.” Lexicon CEO Lonnel Coats expects the drug to hit the market by the end ...
- Source: drugdu
- 111
- May 30, 2023

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