ANI Pharmaceuticals Re-files SNDA For Cortrophin Gel

ANI Pharmaceuticals, Inc. (ANIP) on Tuesday said it has re-filed its supplemental new drug application (sNDA) for Cortrophin Gel with the U.S. Food and Drug Administration

In April 2020, the FDA had rejected the company's sNDA for Cortrophin Gel citing certain portions of the Chemistry, Manufacturing and Controls section in the sNDA were not sufficiently complete.

Purified Cortrophin Gel is approved for a variety of indications including multiple sclerosis, rheumatoid arthritis, systemic lupus among others.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Boeing expects Europe's commercial aviation fleet to need 8,705 new airplanes through 2040 to cater to the growing leisure travel market in the region and fleet replacements with more fuel-efficient models, according to the Boeing's 2021 Commercial Market Outlook (CMO), an annual forecast of long-term demand for commercial airplanes and services. The U.S. Food and Drug Administration authorized marketing of a software developed by Paige.AI, a provider of AI-based digital diagnostics, which could help pathologists to identify prostate cancer. The software, called Paige Prostate, is the first and only artificial intelligence or AI-based pathology product to receive FDA approval for in vitro diagnostic or IVD use in detecting cancer... General Mills (GIS) said its first-quarter top- and bottom-line results were ahead of its expectations. The company also reaffirmed its fiscal 2022 outlook. Looking forward, General Mills anticipates changes in consumer behaviors driven by the COVID-19 pandemic will result in ongoing elevated consumer...
Follow RTT