the fda has the authority to decide if a drug is marketed as an otc or prescription-only product.
the fda has the authority to decide if a drug is marketed as an otc or prescription-only product.
who has the authority to decide if a drug is marketed as an otc or prescription-only product?
the fda
syntex first marketed naproxen in 1976 as the prescription drug naprosyn. they first marketed naproxen sodium under the brand name anaprox in 1980. it remains a prescription-only drug in much of the world. in the united states, the food and drug administration (fda) approved it as an over-the-counter (otc) drug in 1994. otc preparations of naproxen in the u.s. are mainly marketed by bayer healthcare under the brand name aleve and generic store brand formulations in 220mg tablets. in australia, packets of 275mg tablets of naproxen sodium are schedule 2 pharmacy medicines, with a maximum daily dose of five tablets or 1375mg. in the united kingdom, 250mg tablets of naproxen were approved for otc sale under the brand name feminax ultra in 2008, for the treatment of primary dysmenorrhoea in women aged 15 to 50. in the netherlands, 220mg and 275mg tablets are available otc in drugstores, 550mg is otc only at pharmacies. aleve became available over the counter in most provinces in canada on 14 july 2009, but not british columbia, quebec or newfoundland and labrador; it subsequently became available otc in british columbia in january 2010.
naproxen
as a general rule, "over-the-counter drugs" (otc) are used to treat a condition that does not need care from a healthcare professional if have been proven to meet higher safety standards for self-medication by patients. often, a lower strength of a drug will be approved for otc use, but higher strengths require a prescription to be obtained; a notable case is ibuprofen, which has been widely available as an otc pain killer since the mid-1980s, but it is available by prescription in doses up to four times the otc dose for severe pain that is not adequately controlled by the otc strength.
prescription drug