FDA Seeks to Pull Nearly 250 ANDAs Over Unsubmitted Annual Reports
The US Food and Drug Administration (FDA) on Wednesday said it plans to withdraw the approval of 249 abbreviated new drug applications (ANDAs) after their manufacturers repeatedly failed to submit annual reports for the generic drugs.FDA says the manufacturers will have the opportunity to request a hearing to appeal the decision by filing a written request and providing the agency with a rationale for why the ANDA should not be withdrawn.
“A request for a hearing may not rest upon mere allegations or denials but must present specific facts showing there is a genuine and substantial issue of fact that requires a hearing,” FDA writes, noting that it may deny a hearing if the request is “not complete or is not supported.”
Generic drugmakers are required to submit annual reports for approved ANDAs under 21 CFR Sections 314.81 and 314.98.
Some of the companies impacted include major drugmakers and their subsidiaries, including Pfizer Laboratories, Novartis’ Sandoz and Fresenius USA, although the vast majority of the companies are smaller manufacturers.
In total, FDA is proposing to withdraw 249 products from 89 companies, with four companies facing withdrawal of 10 or more ANDAs.
| Company | Proposed ANDAs to be Withdrawn |
| Alra Laboratories | 28 |
| American Therapeutics, Inc. | 26 |
| Ambix Laboratories | 11 |
| Wockhardt EU Operations | 10 |
| Wendt Laboratories | 9 |
| MK Laboratories | 8 |
| Shire Richwood, Inc. | 8 |
| ABC Holding Corp. | 8 |
| Leiner Health Products, Inc. | 6 |
| Lederle Laboratories | 5 |
| Everylife | 5 |
| Rexall Drug Co. | 4 |
| American Antibiotics Inc. | 4 |
| MM Mast and Co. | 4 |
| Jerome Stevens Pharmaceuticals | 4 |
| Marshall Pharmacal | 4 |
| Warner-Lambert Co. | 4 |
| Camall Co., Inc. | 4 |
| West-Ward Pharmaceutical Corp | 3 |
| Johnson and Johnson Medical, Inc. | 3 |
| Private Formulations, Inc. | 3 |
| Scherer Laboratories | 3 |
| Chartwell RX Sciences, LLC | 3 |
| MIPS Cyclotron and Radiochemistry | 3 |
| Miza Pharmaceuticals | 3 |
| WE Pharmaceuticals, Inc. | 2 |
| Pfizer Laboratories, Division of Pfizer, Inc. | 2 |
| Landela Pharmaceutical | 2 |
| Optopics Laboratories Corp. | 2 |
| Valeant Pharmaceuticals International | 2 |
| Xanodyne Pharmacal, Inc. | 2 |
| Dell Laboratories | 2 |
| Anabolic, Inc. | 2 |
| CM Bundy Co. | 2 |
| Fleming and Co. Pharmaceuticals | 2 |
| Abbott Laboratories | 2 |
| Fresenius USA | 1 |
| Eastman Kodak Co. | 1 |
| Parkedale Pharmaceuticals | 1 |
| John D Copanos and Co | 1 |
| Roerig, Division of Pfizer, Inc. | 1 |
| Kasco-EFCO Laboratories | 1 |
| Proter S.p.A., c/o Richmar International | 1 |
| Pharmacia and Upjohn Co. | 1 |
| Owen Laboratories, Division of Alcon | 1 |
| Chromalloy Pharmaceuticals | 1 |
| Watson Laboratories | 1 |
| Apothekernes Laboratorium A.S. | 1 |
| AH Robins Co. | 1 |
| Pliva | 1 |
| Takasaki Plant, Nippon Kayaku Co., Ltd. | 1 |
| Chemiewerk Homberg | 1 |
| Ceph International Corp. | 1 |
| Pharmaceutical Specialist Association | 1 |
| Syosset Laboratories | 1 |
| BOCA Pharmacal, LLC | 1 |
| Matrix Medical Crop. | 1 |
| Soapco, Inc. | 1 |
| Milex Products Inc. | 1 |
| Beckton Dickinson Surgical System | 1 |
| Mutual Pharmaceutical Co., Inc. | 1 |
| Laboratorios Applicaciones | 1 |
| Theragen | 1 |
| Cook Imaging Corp. | 1 |
| Martec USA, LLC | 1 |
| Pharmascience, Inc. | 1 |
| Trace Life Sciences | 1 |
| Avacor Products, LLC | 1 |
| Fresenius Medical Care North America | 1 |
| Bio-Nucleonics, Inc. | 1 |
| Arco Pharmaceuticals, LLC | 1 |
| C and M Pharmacal, Inc. | 1 |
| Elkins Sinn Pharmaceutical Co. | 1 |
| Phoenix Laboratories, Inc. | 1 |
| Holland Rantos Co., Inc. | 1 |
| Glenwood, Inc. | 1 |
| Sandoz | 1 |
| Zzeon Pharmaceuticals, Ltd. | 1 |
| Pharmaton, Ltd. | 1 |
| Polymedica Industries, Inc. | 1 |
| Rexar Pharmacal | 1 |
| BH Chemicals, Inc. | 1 |
| Tablicaps, Inc. | 1 |
| Mericon Industries | 1 |
| Bioglan Laboratories, Ltd. | 1 |
| Pharmaceutical Ventures, Ltd. | 1 |
| Pharma Serve, Inc. | 1 |
| Bedford Laboratories | 1 |
| Numark Laboratories | 1 |
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