Barr's generic Adderall cleared in USA
Barr Laboratories has received approval from the US Food and DrugAdministration for generic Adderall (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate) tablets, 7.5mg, 12.5mg and 15mg. This mixed salts of a single-entity amphetamine product is an AB rated generic equivalent of Shire US' branded Adderall, used in the treatment of attention deficit hyperactivity disorder. Barr says it will launch these three product strengths immediately.
The company said that it has been granted 180 days of generic exclusivity, commencing at launch, as a result of being the first to file an Abbreviated New Drug Application containing a Paragraph IV certification for the listed patent, adding that the patent holder did not file suit against Barr within the statutory 45-day period.
In February 2002, Barr was the first to market and launch a generic equivalent to Shire's Adderall 5mg, 10mg, 20mg and 30mg.
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