🚫FDA Issues 10-Year Debarment Order Against Harpreet Singh
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Harpreet Singh for a period of 10 years from importing or offering for import any drug into the United States. FDA bases this order on a finding Mr. Singh was convicted of multiple felony offenses, which serve as the basis for this debarment, that are conspiracy to possess with intent to distribute cathinone, tapentadol, tramadol, and carisoprodol; one felony count under Federal law for fraudulent importation and transportation of goods; one felony count under Federal law for conspiracy to launder money; and one felony count under Federal law for conspiracy to obstruct justice. The factual basis supporting Mr. Singh's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Singh was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of November 20, 2024 (30 days after receipt of the notice), Mr. Singh had not responded. Mr. Singh's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Learn More⚖️FDA Debarment Order Against Jonathan Corbett Cosie
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jonathan Corbett Cosie for a period of 10 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Cosie was convicted of two felony counts under Federal law for introducing misbranded drugs into interstate commerce with the intent to defraud and mislead. The factual basis supporting Mr. Cosie's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Cosie was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of January 6, 2025 (30 days after receipt of the notice), Mr. Cosie had not responded. Mr. Cosie's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Learn More🧪FDA Issues Priority Review Voucher for Gomekli Product
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that GOMEKLI (mirdametinib), approved on February 11, 2025, manufactured by SpringWorks Therapeutics, Inc., meets the criteria for a priority review voucher.
Learn More🚫FDA Debars Alnashir Punjani for 5 Years
The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Alnashir Alibhai Punjani for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Punjani was convicted of one felony count under Federal law for conspiracy to deliver and introduce unapproved drugs. The factual basis supporting Mr. Punjani's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Punjani was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of November 10, 2024 (30 days after receipt of the notice), Mr. Punjani had not responded. Mr. Punjani's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Learn More💊FDA Determines RIOMET Not Withdrawn, Impacts Drug Approvals
The Food and Drug Administration (FDA or Agency) has determined that RIOMET (metformin hydrochloride) Oral Solution, 500 milligrams (mg)/5 milliliters (mL) has not been withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Learn More💊DEA Notice for Aphena Pharma As Controlled Substances Importer
Aphena Pharma Solutions MD, 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.
Learn More💊Catalent Pharma's Application for Controlled Substance Importing
Catalent Pharma Solutions, 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.
Learn More💊Purisys LLC Applies for Registration as Bulk Manufacturer of Controlled Substances
Purisys, LLC 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💊Patheon API Inc. Seeks Registration as Bulk Manufacturer of Controlled Substances
Patheon API 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⚖️Siegfried USA, LLC's Bulk Manufacturer Application Notice and Compliance Information
Siegfried USA, LLC 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.
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