FDA Nods Generic Dexilant Application
The FDA has accepted the new drug application by Handa Pharmaceuticals for Dexlansoprazole delayed-release capsules.
Handa Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has accepted its abbreviated new drug application for Dexlansoprazole delayed-release capsules. The FDA will now review the drug in its 60mg dosage.
Dexlansoprazole delayed-release is the generic version of Takeda’s popular Dexilant, and is used as an oral treatment for heartburn associated with symptomatic non-erosive gastroesophageal reflux disease.
Annual sales of Dexilant in the US reached approximately $300m in 2010.
Related News
-
News US FDA announces new priority vouchers for accelerated review times
The US FDA announced a new priority program for drug developers – the Commissioner’s National Priority Voucher (CNPV) program aims to enhance the health interests of the US by allowing drug developers to redeem a voucher, shortening th... -
News CPHI Podcast Series: US drug policy – exploring the executive orders
The latest episode of the CPHI Podcast Series provides a timely overview of the recent policy changes in the USA, with President Trump signing excecutive orders to change drug pricing under a 'Most Favoured Nation' scheme.
-
News PhRMA trade association issues comments on Section 232 investigation
The Pharmaceutical Research and Manufacturers of America (PhRMA), an American trade association representing groups in the pharmaceutical industry, issued a letter on May 6, 2026 to the Department of Commerce regarding the Section 232 National Security... -
News Pharmaceutical Packaging Market Prospects: Shifting regional policies
The pharmaceutical packaging industry is experiencing significant transformation in 2025, driven by regulatory changes, supply chain challenges, and sustainability initiatives. The US BIOSECURE Act, passed through the House of Representatives in Septem... -
News The next 15 drugs up for negotiation with Medicare include several blockbusters
By now, everyone is quite familiar with the drug price negotiations taking place between drug companies and the Centres for Medicare & Medicaid Services (CMS) in the USA as part of measures being taken to reduce the cost of drugs for patients, to make ... -
News PSCI Welcomes Delpharm, Samsung Biologics, and Suven as First Supplier Partners
The pharmaceutical industry continues to evolve with an increasing focus on responsible sourcing, sustainability, and collaboration across the supply chain. Under a new model to recognise suppliers within the pharmaceutical and healthcare industry that... -
News Drug prices agreed upon as part of the US Inflation Reduction Act
The Inflation Reduction Act brought into constitution by the Biden administation in 2022, which proposed a drug price negotiation between the government and pharmaceutical companies, has reached it's first agreement.
-
.png)
News Eisai Alzheimer’s drug authorised in UK but still faces obstacles
In partnership with BioArctic AB, pharmaceutical company Eisai has been granted Marketing Authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) for its Alzheimer’s disease drug product Leqembi.