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The Latest FDA Approved Generic Medication and New Pharmaceuticals

SelzentryTM (Maraviroc) Tablets by Pfizer – new class of oral HIV medicines

Published by admin | Filed under New Drugs

Pfizer’s SelzentryTM (Maraviroc) Tablets, Novel Treatment for HIV, Approved by FDA First in a New Class of Oral HIV Medicines in More Than a Decade Pfizer Inc announced that the U.S. Food and Drug Administration (FDA) has approved SelzentryTM (maraviroc) tablets, the first in a new class of oral HIV medicines in more than 10 [...]

August 8th, 2007. Comment now »

SANCTURA(R) XR by Indevus Pharmaceuticals – treatment of overactive bladder

Published by admin | Filed under New Drugs

Indevus Pharmaceuticals, Inc. announced that SANCTURA(R) XR (trospium chloride extended release capsules) has been approved by the U.S. Food and Drug Administration (FDA). SANCTURA XR is indicated for the once- daily treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. SANCTURA XR, the once-daily formulation of SANCTURA(R), is a [...]

August 8th, 2007. Comment now »

Generic Protonix®: PANTOPRAZOLE SODIUM by Teva Pharmaceutical

Published by admin | Filed under Generic Drugs

Jerusalem, Israel, August 2, 2007 – Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today 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 Wyeth’s Protonix® (Pantoprazole Sodium) Delayed Release (DR) Tablets, 20 mg and 40 mg. Teva’s Pantoprazole Sodium [...]

August 8th, 2007. Comment now »

Generic Zaditor™: ketotifen fumarate by AKORN

Published by admin | Filed under Uncategorized

BUFFALO GROVE, Ill. – Akorn, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted approval for Over-the-Counter (OTC) use of Akorn’s Abbreviated New Drug Application (ANDA) for Ketotifen Fumarate Ophthalmic Solution, 0.025%. Akorn’s Ketotifen Fumarate Ophthalmic Solution, 0.025% is the generic equivalent of Novartis’ Zaditor® Ophthalmic Solution 0.025%. Zaditor® was recently granted [...]

August 1st, 2007. Comment now »

VIVUS, Inc. introduces Evamist(TM) estradiol transdermal spray

Published by admin | Filed under New Drugs

MOUNTAIN VIEW, Calif., Jul 30, 2007 – VIVUS, Inc. announced that it has received US Food and Drug Administration (“FDA”) approval for the marketing of Evamist(TM), a metered dose transdermal estradiol spray for the treatment of moderate to severe vasomotor symptoms due to menopause. Evamist is the first estradiol transdermal spray approved by the FDA. [...]

August 1st, 2007. Comment now »