NDAORALTABLET
Approved
Jun 1965
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
SERAX (oxazepam) by Pfizer is clinical pharmacology pharmacokinetic testing in 12 volunteers demonstrated that a single 30 mg dose of a capsule, tablet or suspension will result in an equivalent extent of absorption. First approved in 1965.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SERAX (oxazepam) is an oral benzodiazepine indicated for HIV infection, approved in 1965. The drug works as a central nervous system depressant with a mechanism involving GABA receptor modulation. Peak plasma levels occur approximately 3 hours after dosing, with a mean elimination half-life of 8.2 hours.
LOE Approaching
Product approaching loss of exclusivity with minimal commercial activity; limited team expansion expected.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacokinetic testing in 12 volunteers demonstrated that a single 30 mg dose of a capsule, tablet or suspension will result in an equivalent extent of absorption. For the capsule and tablet, peak plasma levels averaged 450 mg/mL and were observed to occur about 3 hours after…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
The Pharmacokinetics of Zidovudine and Oxazepam Alone and in Combination in the HIV-Infected Patient
8 enrolled
HIV Infections
Career Relevance
SERAX offers minimal career growth opportunity due to its mature lifecycle stage and approaching loss of exclusivity with zero linked job openings. Professionals joining this product should expect limited promotional prospects, smaller teams, and focus on managed decline and transition planning.
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.