Drugs / Pregabaline
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | Lyrica | neuropathy, painful | — | “Pfizer launched pregabalin in the U.S. and Europe with the brand name, Lyrica® and has filed a New Drug Application (NDA) in Japan.” eisai.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial | ||||||
| Phase 3 | NCT01811251 | Dec 2012 → Sep 2017 | — | University Hospital, Clermont-Ferrand | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT03276689 | Oct 2017 → Dec 2020 | neuropathy, painful | Rambam Health Care Campus | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2/3 | NCT02724293 Comparator | Sep 2014 → Oct 2015 | — | Assiut University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2022-12-10 | Zydus Lifesciences Limited | Regulatory Zydus receives two final approvals from the USFDA for Silodosin capsules and Pregabalin capsules zyduslife.com ↗
The company also received the final approval to market Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg (USRLD: Lyrica capsules). |
| 2022-12-01 | Alembic Pharmaceuticals Ltd. | Regulatory 22nd December, 2022, Vadodara, India alembicpharmaceuticals.com ↗
This is the first product approval from Jarod Facility which was inspected in Dec 2022. |
| 2022-08-31 | Zydus Lifesciences Limited | Regulatory Zydus receives two final approvals from the USFDA zyduslife.com ↗
The company also received the final approval from USFDA to market Pregabalin Extended-Release Tablets, USP 82.5 mg, 165 mg and 330 mg. |
| 2022-05-06 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Pregabalin Capsules lupin.com ↗
Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg to market a generic equivalent of Lyrica® Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg of Upjohn US 2 LLC. |
| 2020-08-18 | Upsher-Smith Laboratories | Regulatory Sawai Receives Approvals for 4 Generic Drugs with 13 Strengths upsher-smith.com ↗
Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Kenzo Sawai) received approvals by the Ministry of Health, Labour and Welfare for 4 generic drugs with 13 strengths. |
| 2018-12-15 | Zydus Lifesciences Limited | Regulatory Zydus receives approvals from the USFDA for Albendazole Tablets and Pregabalin Capsules zyduslife.com ↗
The group also received a tentative approval for Pregabalin Capsules (US RLD – Lyrica) in the strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg. |
| 2017-02-21 | Eisai Inc. | Regulatory APPROVAL RECEIVED FOR PAIN TREATMENT LYRICA® OD TABLET FORMULATION IN JAPAN eisai.com ↗
Pfizer Japan Inc. (Headquarters: Tokyo, President and Representative Director: Ichiro Umeda,“Pfizer”) announced today that it received marketing and manufacturing approval in Japan on February 17 for Lyrica® OD Tablets 25mg, 75mg, 150mg (OD tablet: orally disintegrating tablet), a new formulation following pain treatment Lyrica Capsules (pregabalin). |
| 2015-03-12 | Pfizer | Results Pfizer Reports Top-Line Results From A Phase 4 Study Evaluating LYRICA® Capsules CV As A Treatment For Adolescents With Fibromyalgia pfizer.com ↗
Pfizer Inc. (NYSE:PFE) announced today top-line results of a double-blind Phase 4 study evaluating the safety and efficacy of Lyrica® (pregabalin) Capsules CV in adolescents (ages 12-17 years) with fibromyalgia (FM). |
| 2013-02-28 | Eisai Inc. | Regulatory NEW INDICATION APPROVED IN JAPAN FOR LYRICA® CAPSULES eisai.com ↗ |
| 2012-06-22 | Eisai Inc. | Regulatory Lyrica® Capsules Approved in Japan for Additional Indication of Pain Associated with Fibromyalgia eisai.com ↗
Pfizer Japan Inc. (Headquarters: Tokyo, President: Ichiro Umeda, “Pfizer”) announced today that it has received approval to market Lyrica® Capsules (pregabalin, “Lyrica”) in Japan for the additional indication of pain associated with fibromyalgia. |
| 2010-04-16 | Eisai Inc. | Regulatory Lyrica® has been approved for treatment of postherpetic neuralgia eisai.com ↗
Pfizer Japan Inc. (Head Office: Tokyo; President: Ichiro Umeda) announced that Lyrica® Capsules (generic name: pregabalin) has been approved today in Japan for the treatment of postherpetic neuralgia. |
All press releases naming this drug 22 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | pregabaline | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02724293 ↗ |
| Known as | LYRICA | “the patient will receive, according to randomization, premedication with pregabalin LYRICA ® or placebo orally.” NCT01811251 ↗ |
| Known as | pregabalin | “the patient will receive, according to randomization, premedication with pregabalin LYRICA ® or placebo orally.” NCT01811251 ↗ |
| Route | Oral | “premedication with pregabalin LYRICA ® or placebo orally” NCT01811251 ↗ |