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2009 NOV 16 ... a final approval from the US Food and Drug Administration (FDA) for Sun Pharma's Abbreviated New Drug Application (ANDA) for generic Acular=AE opthalmic solution on the first day following patent ...
2009 NOV 1 ... matrix appear to be both safe and well tolerated by patients. The Phase 2b study was abbreviated and enrollment ended early after key efficacy measures among blinded groups were ... 2b clinical study represents a major advance in our plans to establish an important new therapeutic class of biologics for the potential treatment of diabetic foot ulcers and ... Keywords: Clinical Trial Research, Clinical Trials, Diabetes, Diabetic Foot, Drug Development, Endocrinology, FDA, Foot Ulcer, Pharmaceuticals, Pre-Trials Research, ... published studies reflected in the prescribing information sheet for becaplermin, daily application of product combined with daily wound cleansings resulted in a 35% relative improvement ...
2009 NOV 2 ... receipt of a Paragraph IV Certification Notice Letter on October 20, 2009 regarding an Abbreviated New Drug Application (ANDA) submitted to the U.S. Food and Drug Administration (FDA) by Teva Pharmaceuticals ...
2009 NOV 16 ... Mallinckrodt Inc., has received U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for Oral Transmucosal Fentanyl Citrate (CII). Covidien's product is ...
2009 NOV 23 ... IV certification notice from Lupin Limited advising Depomed of the filing of an Abbreviated New Drug Application (ANDA) with the FDA for a generic version of GLUMETZA® (metformin hydrochloride ...
2009 NOV 9 ... to five-year market exclusivity. The FDA therefore appropriately refused to file the Abbreviated New Drug Application submitted by Actavis Elizabeth, LLC (Actavis) for generic lisdexamfetamine dimesylate in ...
2009 NOV 23 ... He has extensive experience in the area of generic pharmaceuticals, including the Abbreviated New Drug Application Process and the complexities of litigation involving pharmaceuticals under the ...
2009 NOV 16 ... its TRICOR® (fenofibrate) tablets, 48 mg and 145 mg. Impax filed its Abbreviated New Drug Application ("ANDA") containing a Paragraph IV certification for a generic version of TRICOR® ...
2009 NOV 1 ... Mylan's Matrix was the first company to submit a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification to the U.S. Food and Drug Administration ...
2009 NOV 23 ... has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lansoprazole Delayed-release (DR) Capsules, 15 mg and 30 mg. This product is ...
2009 NOV 2 ... had been sued by Stiefel for infringement of a patent related to KV's filing of an Abbreviated New Drug Application (ANDA) for a generic to Duac® Gel in the United States District Court for the ...
2009 NOV 2 ... had been sued by Stiefel for infringement of a patent related to KV's filing of an Abbreviated New Drug Application (ANDA) for a generic to Duac=AE Gel in the United States District Court for the District ...
2009 NOV 1 ... Perrigo Company (NASDAQ: PRGO) announced that it has filed an Abbreviated New Drug Application for over-the-counter (OTC) Minoxidil topical aerosol foam, 5%, a generic form of Men's ...
2009 NOV 23 ... Roxane Laboratories, Inc. announced the approval of its Abbreviated New Drug Application (ANDA) for Perindopril Erbumine Tablets, 2mg, 4mg and 8mg by the U.S. Food and Drug ...
2009 NOV 1 ... all pending litigation with Sandoz, Inc. ("Sandoz") in connection with Sandoz's Abbreviated New Drug Application ("ANDA") and its attempt to market generic versions of Shire's ADDERALL XR® ...
2009 NOV 2 ... Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) commented today on the abbreviated new drug application (ANDA) containing a Paragraph IV certification for COPAXONE® (glatiramer acetate ...
2009 NOV 23 ... that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Tap Pharmaceutical's proton pump inhibitor ...
2009 NOV 9 ... System, 3.9mg/24hr.) product. On August 19, 2008, Barr submitted an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Oxytrol=AE. Under terms of the ...
