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FDA: Mouth rinse products cannot have 'prevents gum disease' claim
SILVER SPRING, Md. The Food and Drug Administration on Tuesday issued warning letters to three companies that manufacture and market mouth rinse products with claims that they remove plaque above the gum line or promote healthy gums. According to the FDA, these claims suggested the products are effective in preventing gum disease when no such benefit has been demonstrated.
Warning letters were sent to: Johnson & Johnson (Listerine total care anti-cavity mouthwash), CVS (CVS complete care anti-cavity mouthwash), and Walgreens (Walgreen mouth rinse full action).
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Sun Pharma gets FDA approval for ALS generic
MUMBAI, India The Food and Drug Administration has approved a generic version of a drug for a devastating muscular disorder.
Sun Pharmaceutical Industries announced Tuesday the approval of riluzole hydrochloride in the 50-mg strength. The tablets are used to treat amyotrophic lateral sclerosis or ALS, also known as Lou Gehrig’s disease.
The drug is a generic version of Sanofi-Aventis’ Rilutek, which has sales of around $50 million, according to Sun.