Announced details
Ischemic diseases
The Company’s trademark and generic name for the product under development were assessed, confirmed, and adopted by the FDA division, USPTO, and USAN Council, respectively.
The Advertising and Promotional Labeling Branch under the FDA’s CBER, the U.S. Patent and Trademark Office, and the USAN Council. Other information, including location, representative, capital, and year of establishment, is not disclosed.
The registered trademark remains valid. The registration number and expiration date are not disclosed.
In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.
Advertising and Promotional Labeling Branch (APLB) of the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA); U.S. Patent and Trademark Office (USPTO); USAN Council
| Item | Details |
|---|---|
| Names of Products / Services Covered | HGF gene therapy product, COLLATEGENE®, beperminogene perplasmid |
| Counterparty | Advertising and Promotional Labeling Branch (APLB), Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA), U.S. Patent and Trademark Office (USPTO), USAN Council |
| Counterparty overview | The Advertising and Promotional Labeling Branch under the FDA’s CBER, the U.S. Patent and Trademark Office, and the USAN Council. Other information, including location, representative, capital, and year of establishment, is not disclosed. |
| Relationship with the Company | The Company’s trademark and generic name for the product under development were assessed, confirmed, and adopted by the FDA division, USPTO, and USAN Council, respectively. |
| Applicable area | Ischemic diseases |
| Registration number and expiry date | The registered trademark remains valid. The registration number and expiration date are not disclosed. |
| Source | Advertising and Promotional Labeling Branch (APLB) of the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA); U.S. Patent and Trademark Office (USPTO); USAN Council |
Items this document does not state (11)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.The FDA’s APLB determined that “COLLATEGENE®” is currently available for use, the USPTO confirmed that the registered trademark remains valid, and the USAN Council adopted “beperminogene perplasmid” as the generic name.