Tuesday 24 March, 2009

USFDA Approvals

Final Approvals
Cefazolin Sodium Injection:
Cephazone Pharma
Fluoxetine Capsules: Alembic Limited, Approval
Minocycline Hydrochloride Extended-Release Tablets: Barr Labs
Pantoprazole Sodium Delayed-Release Tablets: KUDCO Ireland Limited
Prednisolone Sodium Phosphate Oral Solution: Amneal Pharmaceuticals
Levetiracetam Tablets: Apotex
Zolpidem tartrate Tablets: Orexo AB
Apraclonidine Hydrochloride Ophthalmic Solution: Akorn
Omeprazole Delayed-Release Capsules: Dr. Reddy's
Indomethacin Extended-Release Capsules: Avanthi
Leuprolide Acetate Injection: Sun Pharma Global, Inc., Approval
Malathion Lotion: Synerx Pharma
Propranolol Hydochloride Extended-Release Capsules: Upsher-Smith
Ramipril Capsules: Ranbaxy
Glycopyrrolate Tablets:West-ward Pharmaceutical Corp
Methylprednisolone Acetate Injection: Sandoz
Quinapril Hydrochloride and Hydrochlorothiazide Tablets: Ranbaxy
Sertraline Hydrochloride Tablets: AustraPharma
Buspirone Hydrochloride Tablets: Dr. Reddy’s Lab
Citalopram Hydrobrobromide Tablets: Glenmark Generics
Nabumetone Tablets: Actavis Elizabeth
Temodar (Temozolomide) Injection: Schering Corp
Divalproex Sodium Extended-Release Tablets: Zydus Pharma., Mylan, Anchen Pharma (Taiwan)
Granisetron Hydrochloride Tablets: Dr. Reddy's Labs
Carboplatin I.V. Injection: Pharmachemie B.V.
Azelastine Hydrochloride Ophthalmic Solution: Apotex
Bupropion Hydrochloride Extended-Release Tablets: Watson Laboratories
Flumazenil Injection: Hikma Farmaceutica (Portugal)
Ibuprofen Capsules: Banner Pharmacaps
Risperidone Tablets: Cadista Pharmaceuticals
Sulfacetamide Sodium Lotion: Perrigo
Levetiracetam Tablets: Cipla
Stavudine Oral Solution: Cipla LtdLevalbuterol Inhalation Solution: Dey


Tentative Approval
Lopinavir and Ritonavir Tablets: Aurobindo Pharma and Matrix Labs
Lamivudine Tablets: Alkem Labs
Ketorolac Tromethamine Ophthalmic Solution: Alcon, Inc.
Rosiglitazone Maleate Tablets: Sandoz Inc.
Stavudine, Lamivudine and Nevirapine Tablets: Pharmacare Ltd.


(Source: USFDA)

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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