FDA clears Impax Labs' ANDA for generic ADHD med

|By:, SA News Editor

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.

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