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A joint panel of FDA advisers has recommended the agency not approve Merck’s application to convert its cholesterol-lowering statin Mevacor from prescription to OTC status — a move that will likely dampen efforts for OTC switches of other statins that are set to lose patent protection.
The FDA has issued a draft guidance to provide drugmakers with recommendations on how to convert OTC drug monograph labeling to OTC “Drug Facts” format.
The FDA is publishing a draft guidance this week to provide drugmakers with recommendations on how to convert OTC drug monograph labeling to OTC “Drug Facts” format.
The FDA issued a proposed rule Jan. 5 to amend the tentative final monograph (TFM) for OTC drugs that are used to relieve symptoms associated with overindulgence of food and drink to include new indications for products containing bismuth subsalicylate.
A draft compliance guidance from the FDA aims to help firms understand new OTC product labeling requirements as well as prepare new labeling within prescribed implementation compliance dates.
The FDA has released a draft compliance guidance to help firms understand new OTC product labeling requirements as well as prepare new labeling within prescribed implementation compliance dates.
Generic drugmaker Alpharma and OTC drug manufacturer Perrigo have agreed to a settlement with the FTC and various state attorneys general to end an investigation regarding an agreement that gave Perrigo a jump on marketing a children’s ibuprofen suspension product.
The final monograph for OTC nasal-decongestant drug products will be amended to remove the indication “for the temporary relief of nasal congestion associated with sinusitis” and to prohibit use of the terms “sinusitis” and “associated sinusitis” elsewhere in the labeling, under an FDA proposal.
The FDA is proposing to amend the final monograph for OTC nasal-decongestant drug products to remove the indication “for the temporary relief of nasal congestion associated with sinusitis” and to prohibit use of the terms “sinusitis” and “associated sinusitis” elsewhere in the labeling.
Generic firm Barr Pharmaceuticals yesterday resubmitted an application seeking approval for an OTC version of its controversial emergency oral contraceptive, Plan B, which the FDA rejected this spring against the favorable recommendations of a scientific advisory panel.