FLOXN

19/05/2022

09/10/2021

निःसंतान दंपति के लिए उम्मीद की नई किरण.......v conceive home inseametion kit.

23/03/2021

KEYTRUDA is a medicine that may treat certain cancers by working with your immune system. KEYTRUDA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.
KEYTRUDA is a prescription medicine used to treat a kind of skin cancer called melanoma. KEYTRUDA may be used when your melanoma has spread or cannot be removed by surgery (advanced melanoma), or o to help prevent melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery, a kind of lung cancer called non-small cell lung cancer (NSCLC). KEYTRUDA may be used with the chemotherapy medicines pemetrexed and a platinum as your first treatment when your lung cancer, has spread (advanced NSCLC), and is a type called “nonsquamous”, andyour tumor does not have an abnormal “EGFR” or “ALK” gene. o KEYTRUDA may be used with the chemotherapy medicines carboplatin and either paclitaxel or paclitaxel protein-bound as your first treatment when your lung cancer, has spread (advanced NSCLC), andis a type called “squamous”. KEYTRUDA may be used alone as your first treatment when your lung cancer. For details about the KEYTRUDA please contact your healthcare professional.

20/03/2021

FDA approves Sanofi’s Sarclisa for patients with relapsed refractory multiple myeloma

Multiple myeloma is a cancer that forms in a type of white blood cell called a plasma cell. The plasma cells are a type of white blood cell in the bone marrow. With this condition, a group of plasma cells becomes cancerous and multiplies. The disease can damage the bones, immune system, kidneys and red blood cell count.
SARCLISA is a CD38-directed cytolytic antibody indicated, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
SARCLISA should be administered by a healthcare professional, with immediate access to emergency equipment and appropriate medical support to manage infusion-related reactions if they occur.
Ingredients in SARCLISA - Active ingredient: isatuximab-irfc Inactive ingredients: histidine, histidine hydrochloride monohydrate, polysorbate 80, sucrose, and water for injection. Manufactured by: sanofi-aventis U.S. LLC, Bridgewater, NJ 08807, A SANOFI COMPANY, U.S. License No. 1752 SARCLISA is a registered trademark of Sanofi ©2020 sanofi-aventis U.S. LLC

11/02/2021

Sporadic basal cell carcinoma (BCC) is the most frequent malignant tumor in Caucasians (most common skin cancer worldwide). Generally, BCCs grow slowly and rarely metastasize or are fatal. Depending on tumour size, histological subtype (‘infiltrative’, ‘micronodular’ and ‘morphoeic’), tumor localization (mostly face) and perineural spread, some BCCs are considered high risk. Those, and neglected or inadequately treated BCCs, have a greater potential of progressing to locally advanced BCC (laBCC). laBCCs are at least 5.0 cm in maximum dimension, show deep tissue invasion, may metastasize and cause substantial morbidity or even mortality. Because laBCCs are histologically indistinguishable from common BCCs, they are classified according to the phenotypic characteristics as described above.
Most occur on the head and neck, where cosmetic and functional outcomes are critical. BCC can be locally destructive if not diagnosed early and treated appropriately.
On February 9, 2021, the Food and Drug Administration granted regular approval to cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for patients with locally advanced basal cell carcinoma (laBCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom a HHI is not appropriate and granted accelerated approval to cemiplimab-rwlc for patients with metastatic BCC (mBCC) previously treated with a HHI or for whom a HHI is not appropriate.
Cemiplimab-rwlc is a human programmed death receptor-1 (PD-1) blocking antibody. Cemiplimab-rwlc is a recombinant human IgG4 monoclonal antibody that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2. Cemiplimab-rwlc is produced by recombinant DNA technology in Chinese hamster o***y (CHO) cell suspension culture. Cemiplimab-rwlc has an approximate molecular weight of 146 kDa. LIBTAYO (cemiplimab-rwlc) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution with a pH of 6. The solution may contain trace amounts of translucent to white particles. Each vial contains 350 mg of cemiplimab-rwlc. Each mL contains cemiplimab-rwlc 50 mg, L-histidine (0.74 mg), L-histidine monohydrochloride monohydrate (1.1 mg), sucrose (50 mg), L-proline (15 mg), Polysorbate 80 (2 mg), and Water for Injection, USP.
Efficacy was evaluated in Study an ongoing open-label, multi-center, non-randomized trial in patients with advanced BCC (laBCC or mBCC) who had progressed on HHI therapy, had not had an objective response after 9 months on HHI therapy, or were intolerant of prior HHI therapy. Eligibility required that laBCC patients were not candidates for curative surgery or curative RT, per multidisciplinary assessment. All patients received cemiplimab-rwlc 350 mg every 3 weeks for up to 93 weeks until disease progression, unacceptable toxicity, or completion of planned treatment.
The main efficacy outcome measures were confirmed objective response rate (ORR) and duration of response (DOR) as assessed by independent central review. For patients without externally visible target lesions (mBCC), confirmed ORR was assessed according to RECIST 1.1. A composite response assessment incorporating clinical response criteria using digital medical photography together with RECIST 1.1, was used for those with externally visible target lesions (laBCC and mBCC).
Among 84 patients with laBCC, the confirmed ORR was 29% (95% CI: 19, 40) with a median DOR not reached (range: 2.1 to 21.4+ months) and 79% of responders maintaining their response for at least 6 months. Among 28 patients with mBCC, the confirmed ORR was 21% (95% CI: 8, 41) with a median DOR not reached (range: 9 to 23.0+ months), and all responders maintaining their responses for at least 6 months.
Severe adverse reactions are immune-mediated adverse reactions (e.g. pneumonitis, hepatitis, colitis, adrenal insufficiency, hypo- and hyperthyroidism, diabetes mellitus and nephritis) and infusion reactions. The most common adverse reactions (incidence ≥ 20%) were fatigue, musculoskeletal pain, diarrhea, rash, and pruritis.
The recommended dosage of cemiplimab-rwlc is 350 mg as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.
View full prescribing information for Libtayo.
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
This application was granted priority review. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

22/01/2021

follow and share for new drug approval and news.

The FDA granted the approval of Cabenuva and Vocabria to ViiV Healthcare.
As the only company solely focused on HIV, ViiV healthcare go beyond developing new medicines. They take a holistic approach to HIV by developing and supporting sustainable community programs — with and for the HIV community.
The U.S. Food and Drug Administration today approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. This is the first FDA-approved injectable, complete regimen for HIV-infected adults that is administered once a month.
The FDA also approved Vocabria (cabotegravir, tablet formulation), which should be taken in combination with oral rilpivirine (Edurant) for one month prior to starting treatment with Cabenuva to ensure the medications are well-tolerated before switching to the extended-release injectable formulation.
“Currently, the standard of care for patients with HIV includes patients taking daily pills to adequately manage their condition. This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen,” said John Farley, M.D., M.P.H., director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. “Having this treatment available for some patients provides an alternative for managing this chronic condition.”
The safety and efficacy of Cabenuva were established through two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/milliliter) before initiation of treatment with Cabenuva. Patients in both trials continued to show virologic suppression at the conclusion of each study, and no clinically relevant change from baseline in CD4+ cell counts was observed.
The most common adverse reactions with Cabenuva were injection site reactions, fever (pyrexia), fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness and rash. Cabenuva should not be used if there is a known previous hypersensitivity reaction to cabotegravir or rilpivirine, or in patients who are not virally suppressed (HIV-1 RNA greater than 50 copies/milliliter).
Cabenuva and Vocabria were granted Fast Track and Priority Review designation by the FDA.
The FDA granted the approval of Cabenuva and Vocabria to ViiV Healthcare.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating to***co products.

Source: FDA Website release

20/01/2021

What ingredients are prohibited or restricted by FDA regulations?
Although it’s against the law to use any ingredient that makes a cosmetic harmful when used as intended, FDA has regulations that specifically prohibit or restrict the use of the following ingredients in cosmetics:
• Bithionol. The use of bithionol is prohibited because it may cause photocontact sensitization.
• Chlorofluorocarbon propellants. The use of chlorofluorocarbon propellants in cosmetic aerosol products intended for domestic consumption is prohibited.
• Chloroform. The use of chloroform in cosmetic products is prohibited because it causes cancer in animals and is likely to be harmful to human health, too. The regulation makes an exception for residual amounts from its use as a processing solvent during manufacture, or as a byproduct from the synthesis of an ingredient.
• Halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide). These are prohibited in cosmetic products because they may cause serious skin disorders.
• Hexachlorophene. Because of its toxic effect and ability to pe*****te human skin, hexachlorophene (HCP) may be used only when no other preservative has been shown to be as effective. The HCP concentration in a cosmetic may not exceed 0.1 percent, and it may not be used in cosmetics that are applied to mucous membranes, such as the lips.
• Mercury compounds. Mercury compounds are readily absorbed through the skin on topical application and tend to accumulate in the body. They may cause allergic reactions, skin irritation, or neurotoxic problems. The use of mercury compounds in cosmetics is limited to eye area products at no more than 65 parts per million (0.0065 percent) of mercury calculated as the metal and is permitted only if no other effective and safe preservative is available. All other cosmetics containing mercury are adulterated and subject to regulatory action unless it occurs in a trace amount of less than 1 part per million (0.0001 percent) calculated as the metal and its presence is unavoidable under conditions of good manufacturing practice.
• Methylene chloride. It causes cancer in animals and is likely to be harmful to human health, too.
• Prohibited cattle materials. To protect against bovine spongiform encephalopathy (BSE), also known as "mad cow disease," cosmetics may not be manufactured from, processed with, or otherwise contain, prohibited cattle materials. These materials include specified risk materials*, material from nonambulatory cattle, material from cattle not inspected and passed, or mechanically separated beef. Prohibited cattle materials do not include tallow that contains no more than 0.15 percent insoluble impurities, tallow derivatives, and hides and hide-derived products, and milk and milk products.
• Sunscreens in cosmetics. Use of the term "sunscreen" or similar sun protection wording in a product's labeling generally causes the product to be subject to regulation as a drug or a drug/cosmetic, depending on the claims. However, sunscreen ingredients may also be used in some cosmetic products to protect the products’ color. The labelling must also state why the sunscreen ingredient is used, for example, "Contains a sunscreen to protect product color." If this explanation isn’t present, the product may be subject to regulation as a drug.
• Vinyl chloride. The use of vinyl chloride is prohibited as an ingredient of aerosol products, because it causes cancer and other health problems.
• Zirconium-containing complexes. The use of zirconium-containing complexes in aerosol cosmetic products is prohibited because of their toxic effect on lungs of animals, as well as the formation of granulomas in human skin.
What about drug ingredients?
If a product is intended for a therapeutic purpose, such as treating or preventing disease, it’s a drug under the law and must meet those requirements, such as premarket approval by FDA, even if it affects the appearance. The presence of certain ingredients with a therapeutic use that is well-known to the public and industry is one factor that can determine whether a product is intended for use as a drug. FDA makes these decisions on a case-by-case basis. To learn more, see “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?).”
Why are different ingredients prohibited in some other countries?
Different countries and regions regulate cosmetics under different legal frameworks.
Under U.S. law, FDA does not have the authority to require cosmetic manufacturers to submit their safety data to FDA, and the burden is on FDA to prove that a particular product or ingredient is harmful when used as intended. We make these decisions based on reliable scientific information available to us. FDA can take other countries’ decisions into consideration, but we can only take action within the legal and regulatory framework for cosmetics in the United States.

30/12/2020

Myovant Sciences has its first FDA approval in Orgovyx, a new oral treatment for advanced prostate cancer. A once-daily pill, the new medicine could become an attractive option for patients looking to avoid in-person injections during the ongoing COVID-19 pandemic. As per the company statement on website “A new oral androgen deprivation therapy (ADT) prescription medication used in adults for the treatment of advanced prostate cancer.
ORGOVYX is the only ADT medicine that is not an injection.
ORGOVYX will be available in January 2021”
“This approval marks the first oral drug in this class and it may eliminate some patients’ need to visit the clinic for treatments that require administration by a health care provider,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “This potential to reduce clinic visits can be especially beneficial in helping patients with cancer stay home and avoid exposure during the coronavirus pandemic.”
The American Cancer Society estimates that in 2020, there will have been more than 190,000 cases of prostate cancer in the U.S. One of the treatment options for advanced prostate cancer is androgen deprivation therapy, which uses drugs to lower levels of the hormones that help prostate cancer cells grow. Current FDA-approved treatments of this type are injected or placed as small implants under the skin. Orgovyx is an orally administered treatment that works by blocking the pituitary gland from making hormones called luteinizing hormone and follicle-stimulating hormone, thereby reducing the amount of testosterone the testicles are able to make.
The safety and efficacy of Orgovyx was evaluated in a randomized, open-label trial in men with advanced prostate cancer. The patients randomly received either Orgovyx once daily or injections of leuprolide, another hormone-targeting drug, every three months for 48 weeks. The objective was to determine if Orgovyx achieved and maintained low enough levels of testosterone (castrate levels), by day 29 through end of the treatment course. In the 622 patients who received Orgovyx, the castration rate was 96.7%.
The most common side effects of Orgovyx include: hot flush, increased glucose, increased triglycerides, musculoskeletal pain, decreased hemoglobin, fatigue, constipation, diarrhea and increased levels of certain liver enzymes. Androgen deprivation therapies such as Orgovyx may affect the heart’s electrical properties or cause electrolyte abnormalities, therefore healthcare providers should consider periodic monitoring of electrocardiograms and electrolytes. Based on findings in animals and the mechanism of action, Orgovyx can cause fetal harm and loss of pregnancy when administered to a pregnant female; it is advised that males with female partners of reproductive potential use effective contraception during treatment and for two weeks after the last dose of Orgovyx. Due to the drug’s suppression of the pituitary gonadal system, diagnostic test results of the pituitary gonadotropic and gonadal functions conducted during and after taking Orgovyx may be affected.

27/12/2020

paraben
What are parabens, and why are they used in cosmetics?
Parabens are a family of related chemicals that are commonly used as preservatives in cosmetic products. Preservatives may be used in cosmetics to prevent the growth of harmful bacteria and mold, in order to protect both the products and consumers.
The parabens used most commonly in cosmetics are methylparaben, propylparaben, butylparaben, and ethylparaben.
Product ingredient …
See more www.facebook.com/pforpharma

23/12/2020

24/12/2018

December 24, 2018 admin 0 Comment FDA permits marketing of Human Milk Analyzer There is a crying need for analysing breast milk in the neonatal departments of hospitals. This is especially true for premature babies when it is of the greatest importance to consider the nutritional composition of the....