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FDA Approval for Naproxen – Anaprox

The FDA approved Naproxen - Anaprox under two different names at two different times. The first time in the year 1976 under the name Naprosyn by which it was marketed and the second time it was under the name of Anaprox but it was not just naproxen but naproxen sodium in the year 1980. It is still a prescription drug in most of the world and but its availability was limited before. The US FDA approved Naproxen - Anaprox as an over the counter drug in the year 1994 where the OTC preparations were sold under a different name, Aleve.

Naproxen - Anaprox was the development of the Roche group and as mentioned above it was the FDA approved in the year 1976. It underwent several clinical trials before it was introduced by the manufacturer in the market as a proper pill for treatment. The sale of this drug was limited before the FDA approved it in the year 1994 as an over the counter drug. Amongst the many other NSAIDs, Naproxen-Anaprox is said to increase gastrointestinal problems in particular, amongst high dosage users. The Manufacturer of these NSAIDs gets worried about their future sales when false theories break out which leave the drug with a bad name and a bad image in front of people in need of that drug.

Concerns about the drug interfering with the growth and birth defects of the fetus have also been expressed but recently been proven positive and a clear risk has been established. In case these drugs are used according to the doctor’s orders they will most likely not have the undesired effects therefore not increase any risk of birth defects.
 

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