FDA grants controlled substance approvals

Pharmatek Labs has cleared Drug Enforcement Agency requirements for the development and manufacture of Schedule 4 and 5 controlled substances. The contract manufacturer's facility design, security systems, and procedures for manufacturing, handling, storage and disposal all meet DEA approval

Separately, India's Sun Pharmaceuticals last month received approval for generic hydocodone bitartate with acetaminophen (APAP) tablets--its first FDA approval for a controlled substance.

The regulator recently published Assessment of Abuse Potential of Drugs, draft guidance for manufactures developing drugs that have the potential to be abused. The guidance, required with applications for new drugs that may be abused, describes what to include in the assessments, including a proposal for scheduling and study design.

- here's the Pharmatek release
- see the Sun's announcement
- check out the draft guidance

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