Zydus Lifesciences gets USFDA nod to market generic arthritis drug in US
The company has received final approval from the US Food and Drug Administration (USFDA) to market Dexamethasone tablets (1mg), the drug maker said in a statement.
The company has received final approval from the US Food and Drug Administration (USFDA) to market Dexamethasone tablets (1mg), the drug maker said in a statement.
A first information report (FIR) was registered under sections 420 (cheating), 468 (forgery), 273 (sale of noxious food or drink) and other relevant provisions of the Indian Penal Code and the Drugs and Cosmetics Act of 1940, an official said.
Still, affordability remains a challenge. Adults with annual household incomes of $90,000 or greater were more likely than those with lower household incomes to say they have heard "a lot" about these drugs, the poll showed.
The Maryland-based drugmaker's stock more than doubled in Friday trading to $8.97 following the deal as the company also removed a warning notice from February last year that raised doubts about it being in business. At their peak in 2021, shares traded at about $332.
In India, the said vaccine was sold under the brand name Covishield manufactured by the Serum Institute of India (SII) in Pune. After the revelation about Astrazeneca's submission in the UK court, parents of a woman who allegedly died after taking Covishield decided to file a case against SII.
Global demand has outpaced supply for Lilly's Mounjaro and Zepbound as well as Danish rival Novo Nordisk's Wegovy and Ozempic. They belong to a therapy area of GLP-1 receptor agonists, developed to control blood sugar in patients with type 2 diabetes, but have gained popularity for their role in weight loss.
The Food and Drug Administration's move prolongs the wait for Moderna's second approved product, but the company said the vaccine remains on track to be reviewed by a panel of advisers at the U.S. Centers for Disease Control and Prevention (CDC) on June 26 and 27.
The company's U.S. sales have been consistently bolstered by strong demand for its generic version of Revlimid, a blockbuster cancer drug developed by Bristol-Myers Squibb. Cipla launched its version of the drug in September 2022.
Dr Harish Chander, Deputy Director (Quality Control), National Institute of Biologicals (NIB), explained a thorough analysis of the complex environment that surrounds the quality control of pharmaceutical and biological products, highlighting the challenges and efforts of important stakeholders at ETPharma’s Biomolecule Workshop & Connect - Mumbai Chapter.
Japan's biggest drugmaker said it will incur restructuring costs of about 140 billion yen ($899 million) this fiscal year as part of a plan to optimise its workforce, cut costs and strengthen technology.
Acknowledging that the Covid vaccines have helped in preventing numerous deaths, Jayadevan, who is the Co-Chairman of National Indian Medical Association (IMA) Covid Task Force in Kerala, stated that reports of such cases have also been highlighted in many reports.