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1,2 Diaminocyclohexane from Synthesis with Catalysts Pvt Ltd — All About Drugs — ORGANIC CHEMISTRY SELECT
+91- 999-997-2051 firstname.lastname@example.org Website http://www.synthesiswithcatalysts.com/ email@example.com Axay Parmar Founder at Synthesis with Catalysts Pvt. Ltd, firstname.lastname@example.org Basu Agarwal and Dr Razi Abdi email@example.com, firstname.lastname@example.org Synthesis with Catalysts Pvt Ltd was founded with an aim to help aromatic chemical, essential oil, pharmaceutical, API manufacturers to develop new products, increase productivity and improve production methodologies. We have an… […]
As part of the U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud, the agency is reminding consumers to be wary of unapproved products claiming to prevent, treat or cure influenza, or flu. This year’s severe flu season raises new concerns about the potential for consumers to be lured into buying unproven flu treatments, and even worse, buying counterfeit antivirals online from websites that appear to be legitimate online pharmacies. Continue Reading
FDA alerts health care professionals and patients not to use compounded drugs from Cantrell Drug Company; agency seeks action to stop production and distribution
The U.S. Food and Drug Administration is alerting health care professionals and patients not to use drug products produced by Cantrell Drug Company of Little Rock, Arkansas, including opioid products and other drugs intended for sterile injection, that were produced by the company and distributed nationwide. The agency is concerned about serious deficiencies in Cantrell’s compounding operations, including its processes to ensure quality and sterility assurance that put patient safety at risk. Administration of contaminated or otherwise poor quality drug products can result in serious and life-threatening injury or death. Continue reading.
- Molecular FormulaC26H23N7O2
- Average mass465.507 Da
Acalabrutinib, rINN, ACP-196,
FDA 2017 APPROVED, Lymphoma, mantle cell, ACERTA PHARMA
Orphan Drug, breakthrough therapy designation,
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Today, the U.S. Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers. Continue reading.
December 28, 2017
FDA permits marketing of device to treat diabetic foot ulcers
Today, the U.S. Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers.
“Diabetes is the leading cause of lower limb amputations,” said Binita Ashar, M.D., director of the division of surgical devices in FDA’s Center for Devices and Radiological Health. “The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases. Additional options for successfully treating and healing ulcer wounds may help prevent lower limb amputations.”
An estimated 30.3 million people in the United States have been diagnosed with diabetes, according to the Centers for Disease Control and Prevention. Diabetes damages blood vessels and nerves, particularly in the feet, and can lead to severe infections that are difficult to treat. About 25 percent of people with diabetes will experience a foot ulcer in their lifetime. Amputation is sometimes necessary when circulation is so poor that a foot ulcer fails to heal or when treatment fails to stop the spread of an infection.
The Dermapace System is intended to be used in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2(about the size of a soda can top) which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The Dermapace System is an external (extracorporeal) shock wave system that uses pulses of energy, similar to sound waves, to mechanically stimulate the wound. The device is intended for adult patients (22 years and older), presenting with diabetic foot ulcers lasting for more than 30 days, and should be used along with standard diabetic ulcer care.
The FDA reviewed clinical data from two multi-center, randomized, double-blind studies with a total of 336 diabetic patients receiving either usual care, which includes wet-to-dry dressings or debridement (removal of damaged tissue) as needed, plus the Dermapace System shock wave therapy or usual care plus non-working (sham) shock wave therapy. Both patient groups included those with poorly controlled and well-controlled blood glucose levels.
The patients who had between one and seven treatments with the Dermapace System showed an increase in wound healing at 24 weeks with a 44 percent wound closure rate. Those patients treated with the sham shock wave therapy showed a 30 percent wound closure rate during the same time period.
The most common side effects observed were pain during application of the device, local bruising and numbness, migraines, nausea, fainting, wound infection, infection beyond the wound (cellulitis, osteomyelitis) and fever.
The Dermapace System was reviewed through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices of a new type for which there is no legally marketed predicate device to which the device can claim substantial equivalence. This action also creates a new regulatory classification that would allow future devices to go through the FDA’s 510(k) process, whereby devices can demonstrate substantial equivalence to this predicate device.
The FDA permitted marketing of the Dermapace System to Sanuwave, Inc.
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Biocon Launches KRABEVA® in India, A Biosimilar Bevacizumab for Treating Several Types of Cancer
On November 23, 2017, Biocon India’s premier Biopharmaceuticals Company announced that it has launched KRABEVA®, a biosimilar Bevacizumab for the treatment of patients with metastatic colorectal cancer and other types of lung, kidney, cervical, ovarian and brain cancers, in India 1.
KRABEVA®, a monoclonal antibody (mAb) developed by Biocon, will help expand access to a world-class, high quality biosimilar Bevacizumab for cancer patients in India. It is the world´s first and only Bevacizumab with a unique ´QualCheck ´ mechanism, which ensures that patients get a quality-ascertained product right up to infusion.
Bevacizumab is indicated as a first-line treatment of patients with metastatic colorectal cancer (mCRC), and is accepted as a standard treatment option in combination with chemotherapy for patients with non-small-cell lung cancer (NSLC), metastatic renal cell carcinoma or recurrent ovarian cancer.
KRABEVA® is the second key oncologic biosimilar product, from Biocon´s global biosimilars portfolio…
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FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response
Discontinuation in treatment marks a first in chronic myeloid leukemia
The U.S. Food and Drug Administration today updated the product label for the cancer drug Tasigna (nilotonib) to include information for providers about how to discontinue the drug in certain patients. Tasigna, first approved by the FDA in 2007, is indicated for the treatment of patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). With today’s updated dosing recommendations, patients with early (chronic) phase CML who have been taking Tasigna for three years or more, and whose leukemia has responded to treatment according to specific criteria as detected by a test that has received FDA marketing authorization, may be eligible to stop taking Tasigna. Continue reading
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