💊FDA Withdraws Approval of 23 ANDAs from Teva Pharmaceuticals
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on January 15, 2025. The document announced the withdrawal of approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of February 14, 2025. The document indicated that FDA was withdrawing approval of the ANDA 209325 for miglustat capsule, 100 milligrams, held by Breckenridge Pharmaceutical, Inc., 15 Massirio Dr., Suite 201, Berlin, CT 06037. Before FDA withdrew the approval of this ANDA, Breckenridge Pharmaceutical, Inc. informed FDA that they did not want the approval of the ANDA withdrawn. Because Breckenridge Pharmaceutical, Inc., timely requested that approval of ANDA 209325 not be withdrawn, the approval is still in effect. This notice corrects this error.
Learn More💊FDA Finds VIBRAMYCIN Not Withdrawn, Impacts Generic Drug Market
The Food and Drug Administration (FDA, Agency, or we) has determined that VIBRAMYCIN (doxycycline) for oral suspension, equivalent (EQ) 25 milligrams (mg) base/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness.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💰NIH Notice
The Department of Health and Human Services announces a closed meeting by the National Institute on Aging to review grant applications for aging research. The meeting will evaluate applications with potentially sensitive commercial information, ensuring privacy and confidentiality are maintained during the review process.
Learn More🌿Royal Emerald Pharmaceuticals' Application for Controlled Substances Registration
Royal Emerald Pharmaceuticals 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 for Bulk Manufacturer of Marihuana
The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to its regulations governing the program of growing marihuana for scientific and medical research under DEA registration.
Learn More💊FTZ 35 Authorization of Production Activity
The Department of Commerce's Foreign-Trade Zones Board has authorized PCI Pharma Services to conduct production activities within FTZ 35 in Croydon and Philadelphia, Pennsylvania. This notification follows regulatory checks and public commentary and is intended to streamline operational efficiencies for the involved pharmaceutical production facilities.
Learn More💊AHRQ Request for Evidence on Managing Menopausal Symptoms
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Improving the Management of Menopausal Symptoms in Perimenopausal and Early Postmenopausal Women: A Systematic Review, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Learn More💊Sterling Pharma's Application for Bulk Manufacturing of Controlled Substances
Sterling Pharma 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.
Learn More💊FDA Withdraws Approval of Eight Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of eight abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
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.
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