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Mylan Announces Tentative FDA Approval for Paroxetine Hydrochloride Extended-Release Tablets
Mylan Laboratories announced that Mylan Pharmaceuticals Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its ...

Dendreon Announces FDA Confirms Data Required for Provenge(R) Licensure
Dendreon Corporation announced the Company has received confirmation that the U.S. Food and Drug Administration (FDA) will accept either a positive in...

FDA Approves New Drug for Advanced Kidney Cancer
The U.S. Food and Drug Administration (FDA) today approved Torisel (temsirolimus) for the treatment of a certain type of advanced kidney cancer known ...

FDA Approves ZYFLO CR(TM) (Zileuton) Extended-Release Tablets for Critical Therapeutics, DEY Marketing Partner for Chronic Treatment of Asthma
Dey announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) of its marketing partner, Critical Therapeu...

Mylan Announces Final FDA Approval For Fluoxetine Capsules USP, 40 Mg
Mylan Laboratories announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its supp...

Perrigo Receives FDA Approval To Market Coated Fruit Nicotine Gum
The Perrigo Company announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market over-the-counter coated nicotin...

Rexahn Pharmaceuticals Receives FDA Approval to Initiate a Phase II Trial for Archexin in Patients with Renal Cell Carcinoma
Rexahn Pharmaceuticals, a biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative treatments for cancer...

GE Healthcare Receives FDA Clearance For CARESCAPE Patient Data Module For Mobile Patient Monitoring
GE Healthcare announced recently U.S. Food and Drug Administration (FDA) clearance for its CARESCAPE Patient Data Module for mobile patient monitoring...

Novagali Pharma Receives US FDA Orphan Drug Designation For Vekacia For The Treatment Of Vernal Keratoconjunctivitis
Novagali Pharma, an emerging ophthalmic pharmaceutical company, announced orphan drug designation granted by the U.S. Food and Drug Administration (FD...

FDA Approves Lybrel, The First Continuous Use Drug Product for Prevention of Pregnancy
The Food and Drug Administration (FDA) approved Lybrel, the first continuous use drug product for prevention of pregnancy.The new contraceptive, Lybre...

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