# OMLYCLO (omalizumab-igec) by CELLTRION USA, Inc.: new human prescription drug listing

**Launch Signal Score:** 80/100

| Field | Value |
|---|---|
| Product | OMLYCLO |
| Generic name | omalizumab-igec |
| NDC | 72606-035 |
| Labeler | CELLTRION USA, Inc. |
| Product type | HUMAN PRESCRIPTION DRUG |
| Approval pathway | BLA |
| Application number | BLA761399 |
| Dosage form | INJECTION |
| Route | SUBCUTANEOUS |
| Active ingredients | OMALIZUMAB 75 mg/.5mL |
| Marketing start | 2026-10-05 |
| Package configurations | 1 |

## Why this score
- Prescription or biologic product.
- Brand or biologic launch.
- Injectable: hospital and 503B relevance.

Source: U.S. FDA National Drug Code (NDC) Directory via openFDA (https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=72606-035). Last refreshed: 2026-11-03T18:09:00.764Z.
Listing data comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn. Informational only; not medical advice.