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Schering-Plough’s nondrowsy antihistamine Claritin has garnered more than $1 billion in U.S. sales since it was granted OTC status more than two years ago, the firm said.
The FDA is nearing approval of a proposal that will grant OTC status to Barr Pharmaceuticals’ emergency contraceptive Plan B, according to the agency’s acting Commissioner Lester Crawford.
The FDA has cited Florida-based Lex Pharmaceutical following an FDA inspection that revealed multiple manufacturing violations at the company’s Medley, Fla., plant.
The FDA has published a question-and-answer guidance containing recommendations for drugmakers to convert OTC drug monograph labeling to the OTC “Drug Facts” format.
Interest in establishing a “behind-the-counter” (BTC) drug category may be gaining momentum, as lawmakers seek ways to prevent the abuse of common OTC drugs and drugmakers run into hurdles trying to switch their Rx products to OTC status.
The FDA currently can approve drugs for either prescription or OTC use, but a third “behind-the-counter” (BTC) alternative has gained notice in recent weeks, as lawmakers seek ways to prevent the abuse of common OTC drugs and drugmakers run into hurdles trying to switch their Rx products to OTC status.
A bipartisan bill proposing sales restrictions on certain cold medicines commonly used to produce methamphetamine is gaining steam in the Senate, much to the chagrin of advocacy organizations that contend the proposal would limit consumer access to popular cold treatments like Sudafed and Tylenol flu medicine.
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 increase generic competition and dampen efforts for OTC switches of other statins that are set to lose patent protection.
The FDA should not approve Merck’s application to convert its cholesterol-lowering statin Mevacor from prescription to OTC status, according to a joint FDA advisory panel decision that will likely dampen efforts for OTC switches of other statins that are set to lose patent protection.