💊ITC Investigation on Drug Products and Patent Violations
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on April 2, 2025, under section 337 of the Tariff Act of 1930, as amended, on behalf of BioMarin Pharmaceutical Inc. of Novato, California. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain drug products containing C-type natriuretic peptide variants and components thereof by reason of the infringement of certain claims of U.S. Reissue Patent No. RE48,267 (the "RE'267 patent"). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.
Learn More⚖️Revocation of DEA Registration for Mohan Kaza Due to Violations
The Drug Enforcement Administration issued a decision revoking Dr. Mohan Kaza's DEA registration, citing multiple violations of the Controlled Substances Act related to improper prescribing practices. The order reveals serious concerns regarding public safety and compliance with legal standards, ultimately leading to the termination of his ability to prescribe controlled substances.
Learn More💊Importer of Controlled Substances Application by US Pharmacopeial Convention
United States Pharmacopeial Convention has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More💊FDA Notice on Prescription Drug User Fee Program Details
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Learn More💊Almac Clinical Services' Importer Application for Controlled Substances
Almac Clinical Services, Inc., (ACSI) has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More💊Bulk Manufacturer Registration Application by Pisgah Laboratories
Pisgah Laboratories has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More💊DEA Notice on Royal Emerald Pharmaceuticals' Import Application
Royal Emerald Pharmaceuticals has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More💊Patheon API Services Inc. Applies for Controlled Substances Registration
Patheon API Services Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More💊DEA Revokes Eagle Pharmacy Registration
The Drug Enforcement Administration issued an Order to Show Cause against Eagle Pharmacy for alleged violations related to dispensing controlled substances without addressing significant red flags of abuse. The case highlights the stringent regulations governing pharmacies and the potential consequences of non-compliance, including revocation of licenses and operational disruptions.
Learn More💊SpecGx LLC Controlled Substances Import Application Overview
SpecGx LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
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