PillOmalizumab
Brands: Xolair · Xolair Pfs · Omalizumab
1 active makers
soon
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Medicaid dispensing volumeSDUD · per quarter
Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.
Who makes it1 active · 0 exited
US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.
| Labeler | Type | Packages | Status |
|---|---|---|---|
| Genentech, Inc. | unknown | 18 | SUPPLYING |
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Jul 30, 2025RECALLRecall (Class II): Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. — Recalling firm: Cardinal Health Inc. — Nationwide Within the U.S.
- Jul 30, 2025RECALLRecall (Class II): Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: …
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. — Recalling firm: Cardinal Health Inc. — Nationwide Within the U.S.
- Jun 9, 2021RECALLRecall (Class II): Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. Single-Dose Prefilled S…
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point. — Recalling firm: Genentech Inc — Product was distributed nationwide