Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 18

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 18
---

    Carboxyvinyle polymer-containing nanoparticle suspension
     
    December 2030
    March 2032
  
    TOBRADEX ST
     
    Methods for treating inflammation where infection may occur
    Compositions containing tobramycin and dexamethasone
     
    December 2027
    August 2028
  
    VERKAZIA
     
    Methods for treating eye disease
    Compositions of oil-in-water cationic emulsion
    Compositions containing quaternary ammonium compounds
     
    May 2027
    November 2027
    June 2029

 13 

Governmental Regulation

Our business is subject to federal,
state and local laws, regulations, and administrative practices, including, among others: federal, state and local licensure and registration
requirements concerning the operation of pharmacies and the practice of pharmacy; the Health Insurance Portability and Accountability
Act of 1996 (“HIPAA”); the Health Care Reform Law; statutes and regulations of the FDA, the U.S. Federal Trade Commission
(the “FTC”), the U.S. Drug Enforcement Administration and the U.S. Consumer Product Safety Commission, as well as regulations
promulgated by comparable state agencies concerning the sale, advertisement and promotion of the products we sell. The regulatory and
quality compliance environment for compounded drugs has become significantly more rigorous, complex and strict since the passage of The
Drug Quality and Security Act of 2013 (the “DQSA”). The complexity of the current state and federal regulatory environment,
as well as the expected continued evolution of state and federal laws governing pharmaceutical compounding, have presented, and will
continue to present, potentially significant challenges to our business model and the fulfillment of our mission as a company. Below
are descriptions of some of the various federal and state laws and regulations which may govern or impact our current and planned operations.

FDA New Drug Application (NDA)
Process

As discussed in other sections
of this Annual Report, we are pursuing, and may continue to pursue, alone or with project partners, FDA approval to market and sell one
or more of our product candidates through the FDA’s NDA process. As a condition of approval, the FDA or other regulatory authorities
may require further studies, including Phase 4 post-marketing studies, to provide additional data. Other post-marketing studies may be
required to gain approval for the use of a product as a treatment for clinical indications other than