Watson Pharmaceuticals receives FDA approval for mint coated nicotine gum
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Watson Pharmaceuticals, Inc. has received approval from the United States Food and Drug Administration to market its over-the-counter Nicotine Polacrilex Gum USP, coated mint flavor, in the 2 mg and 4 mg strengths.
Nicotine Polacrilex Gum, coated mint flavor, is the generic equivalent of GlaxoSmithKline Consumer Healthcare’s Nicorette (R) fresh mint gum, which is used as an aid to smoking cessation. The market for over-the-counter nicotine gum had annual sales of over $300 million for the twelve months ending September 2008, according to IRI sales data. Watson will make the product available to customers in early January 2009.
“The approval of our mint flavored, coated nicotine gum is a significant addition to our line of generic smoking cessation products,” said Paul Bisaro, Watson’s President and Chief Executive Officer. “We also have applications pending at FDA for additional flavors and look forward further enhancing our line of smoking cessation products.”
Sun Pharmaceutical Industries Ltd. announced that together with its subsidiaries, it has received final approval from U.S. FDA for several Abbreviated New Drug Applications (ANDA). Approval was received for generic hydocodone bitartate with acetaminophen (APAP) tablets. Approval was also received for generic Aredia(R), pamidronate disodium for injection USP, generic Lopid (R), gemfibrozil tablets, USP, and
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Watson Pharmaceuticals, Inc. has announced that its subsidiary, Watson Laboratories, Inc., has received final approval today from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Bupropion Hydrochloride Extended-Release Tablets (XL) in the 150 mg strength. Bupropion Hydrochloride Extended-Release Tablets is the generic equivalent to GlaxoSmithKline’s Wellbutrin XL(R) product,
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Teva Pharmaceutical Industries Ltd. has announced that its subsidiary, Teva Pharmaceuticals USA, Inc., has signed an agreement with AstraZeneca to settle patent litigation involving Teva’s U.S. generic version of AstraZeneca’s Pulmicort (Budesonide) Respules including all claims for patent infringement and damages. Teva launched its generic budesonide respules in the U.S. on November 18, 2008. The
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Nicotine gum has been in use for over 20 years to help smokers quit abruptly yet close to two-thirds of smokers report that they would prefer to quit gradually. Researchers from the University of Pittsburgh and GlaxoSmithKline Consumer Healthcare have now found that smokers who are trying to quit gradually can also be helped by
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Mylan Inc. has announced that its subsidiary, Mylan Pharmaceuticals Inc., received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fluoxetine Capsules USP, 10 mg and 20 mg. Fluoxetine Capsules, indicated for the treatment of premenstrual dysphoric disorder (PMDD) are the generic version of Eli Lilly’s
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