Drug Launch

Key facts

Triggered by

FDA approval of an NDA, BLA or supplemental application

Pre-approval promotion

Promoting an investigational drug as safe or effective is barred, 21 CFR 312.7

Part D new drug review (CMS guidance)

P&T committees aim to review within 90 days and decide within 180 days

Promotional material submission

Filed with FDA on Form FDA 2253 at the time of first use

What is a drug launch?

A drug launch starts well before approval. Companies prepare over months or years: building evidence, planning supply and distribution, engaging payers and training field teams, so the product can reach patients soon after the Food and Drug Administration (FDA) approves a new drug application (NDA) or biologics license application (BLA).

Launches vary in scale. A primary care drug may need a large field force and broad pharmacy distribution, while a rare disease or cell and gene therapy launch may involve a few treatment centers, limited distribution and patient support hubs.

Launch phases and workstreams

Launch work usually spans three phases:

For physician-administered drugs, reimbursement setup is its own workstream. New products are often billed under miscellaneous HCPCS codes, such as J3490 for unclassified drugs, until CMS assigns a product-specific code through its quarterly coding cycle.

• Pre-approval: unbranded disease education, scientific exchange by medical affairs, publication of trial data and payer communication about investigational products within FDA guidance.
• Approval and launch: final labeling, list price (wholesale acquisition cost, or WAC), NDC listing, wholesaler and specialty pharmacy agreements, promotional materials and field force deployment.
• Post-launch: payer coverage decisions, prior authorization support, uptake tracking and expansion to new indications or populations.

Why launches matter

Investors and management watch early launch performance closely, because uptake in the first months shapes expectations for peak sales. Teams track new-to-brand prescriptions (NBRx), share of new patient starts, time to formulary coverage and the share of prescriptions rejected or abandoned at the pharmacy.

Launches also create work across the market. Competitors adjust promotion and contracting, payers build utilization management criteria, and targeting and territory plans must identify the clinicians who treat the indicated population.

Compliance during launch

Promotion must match the approved labeling from the first day. Materials drafted before approval must be revised to the final label, and field teams may not promote uses FDA did not approve. Companies submit promotional materials to FDA on Form FDA 2253 at first use, and products approved under accelerated approval generally must submit promotional materials before they are used.