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Janet Woodcock

FDA issues alert on homeopathic teething tablets, gels

FDA issues alert on homeopathic teething tablets, gels

SILVER SPRING, Md. — The Food and Drug Administration has issued a warning that homeopathic teething tablets and gels may present a health risk to infants and children. The FDA on Friday urged consumers to stop using the products and dispose of any that they have. The agency said the homeopathic teething tablets and gels

FDA rule bans certain antibacterial soaps

FDA rule bans certain antibacterial soaps

WASHINGTON — Over-the-counter consumer antiseptic soaps with certain active ingredients can no longer be marketed, according to a final rule issued by the Food and Drug Administration. The FDA said the final rule, published Tuesday, applies to consumer antibacterial hand and body wash products containing one or more of 19 active ingredients, including triclosan and

NCPA to Congress: More scrutiny of PBMs needed

NCPA to Congress: More scrutiny of PBMs needed

ALEXANDRIA, Va. — In comments to Congress, the National Community Pharmacists Association called for more oversight of pharmacy benefit management (PBM) companies. NCPA said payers, pharmacy patients and pharmacists could see “tangible benefits” from increased transparency into PBM business practices and potential conflicts of interests. The association submitted its comments to the House Committee on

FDA proposes suffix for biosimilar product names

FDA proposes suffix for biosimilar product names

WASHINGTON — Early feedback on the Food and Drug Administration’s proposal on naming conventions for biosimilars shows a mixed response. Late late week, the FDA published draft guidance recommending that reference biologic products and biosimilars have nonproprietary names that share a core drug substance name and an FDA-designated suffix unique for each product. For interchangeable

FDA OKs first drug for women’s sexual desire disorder

FDA OKs first drug for women’s sexual desire disorder

RALEIGH, N.C. — Sprout Pharmaceuticals Inc. has gained Food and Drug Administration clearance to market Addyi, which the company calls the first FDA-approved medication for hypoactive sexual desire disorder (HSDD) in women. Sprout said late Tuesday that Addyi (flibanserin, 100 mg) is slated to be released by Oct. 17. “It has been a remarkable journey to

Sandoz biosimilar receives backing of FDA panel

WASHINGTON — A Food and Drug Administration panel has recommended that the agency approve what could become the country’s first biosimilar. The panel unanimously urged approval of Sandoz’s filgrastin (Neupogen), a cancer treatment. “This encouraging step forward means that it is very likely now only a question of when, rather than if, filgrastin will be available