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Alembic Pharmaceuticals Ltd on Friday said it has received approval from the US health regulator for its generic version of Carbidopa, Levodopa and Entacapone tablets used in treatment of Parkinson's disease. The approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) of Carbidopa, Levodopa and Entacapone tablets of strengths 12.5 mg/50 mg/200 mg; 18.75 mg/75 mg/200 mg; 25 mg/100 mg/200 mg; 31.25 mg/125 mg/200 mg; 37.5 mg/150 mg/200 mg; and 50 mg/200 mg/200 mg, Alembic Pharmaceuticals Ltd said in a regulatory filing. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Stalevo tablets of similar strengths of Orion Corporation, it added. Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson's disease, the company said.
Zydus Lifesciences on Friday said the US health regulator has granted Orphan Drug Designation to Desidustat, a novel oral product medication for the treatment of Sickle Cell Disease. The US Food and Drugs Administration's (USFDA) grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 2 lakh people in the US. "This Orphan Drug Designation from the USFDA underlines the urgent medical need to develop a therapy for sickle cell disease. We believe that Desidustat can address this unmet need," Zydus Lifesciences MD Sharvil Patel said in a statement. Therapeutic options for management of Sickle Cell Disease are currently limited. A Phase II, double blind, randomised, placebo controlled, parallel, multi-centre, proof-of-concept study to evaluate the efficacy and safety of Desidustat oral tablet for treatment of SCD has been completed, and data will be published in a medical journal, the drug firm said. Orphan drug designation by
The Ayush Ministry on Wednesday signed an MoU between its export promotion council and Zepto Limited to facilitate online access to Ayush medicines and wellness products across the country. The memorandum of understanding (MoU) aims to strengthen digital discovery while ensuring quality compliance and consumer trust in traditional healthcare products. Zepto is an Indian quick-commerce platform offering delivery of groceries and essentials in a short amount of time. Addressing the occasion through a video message, Union Ayush Minister Prataprao Jadhav said innovation-driven Indian startups are playing a critical role in improving last-mile access to trusted wellness products. He emphasised that partnerships with credible digital platforms such as Zepto demonstrate how technology can be responsibly leveraged at scale to connect India's rich AYUSH heritage with modern, transparent and convenient distribution channels nationwide. The minister further noted that the collaboration align
The Armed Forces Medical Services is exploring the use of drone technology to deliver blood bags, medicines and other medical supplies in hilly and hard-to-reach areas, Director General of AFMS, Surgeon Vice Admiral Arti Sarin, has said. She also said the AFMS was responsible for the health requirements of all four astronauts currently part of the Axiom-4 mission to the International Space Station. Vice Admiral Sarin was speaking on Saturday on the sidelines of a commissioning ceremony for five medical cadets at the Armed Forces Medical College (AFMC) in Pune. She said the AFMS is integrating modern technologies like telemedicine, Artificial Intelligence (AI), point-of-care devices, and drones to strengthen healthcare delivery. We are looking at using drone technology for the supply of blood bags, medicines, and other medical equipment. In fact, we are hoping for a day when even medical evacuations can be carried out using drones, she said. The technology is currently being consid
US regulators will begin offering faster reviews to new medicines that administration officials deem as promoting the health interests of Americans, under a new initiative announced Tuesday. Food and Drug Administration Commissioner Marty Makary said the agency will aim to review select drugs in one to two months. FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months. Since arriving at the FDA in April, Makary has repeatedly told FDA staff they need to challenge assumptions and rethink procedures. In a medical journal commentary published last week, Makary suggested the agency could conduct rapid or instant reviews," pointing to the truncated process used to authorize the first COVID-19 vaccines under Operation Warp Speed. For the new program, the FDA will issue a limited number of national priority vouchers to companies aligned with U.S. national priorities,