- The FDA approves Impax Laboratories' (IPXL +12.9%) abbreviated New Drug Application (ANDA) for attention deficit hyperactivity disorder (ADHD) med dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (mixed salts of a single-entity amphetamine product) extended-release capsules in range of strengths.
- The company plans to transition to the ANDA product from the current generic Adderall XR.
- U.S. annual sales of branded and generic mixed amphetamines are $1.8B.
FDA clears Impax Labs' ANDA for generic ADHD med
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