ELITE PHARMACEUTICALS INC /NV/ - Recent Material Event

Item 8.01Other Events

 

On October 15, 2012, the Company issued a press release informing investors that Elite received approval as of September 28th from the U.S. Food and Drug Administration for generic phentermine capsules 15 mg and 30 mg. Elite also announced that the sole supplier of the active pharmaceutical ingredient (“API”) approved for this phentermine capsule product has restricted the amount of API available to Elite and this will delay the launch of this product.

 

The supply restriction also prevents Elite, and its sales and marketing partner, from meeting growing demand for the phentermine 37.5 mg tablets and is also expected to restrict sales of this product.

 

Elite believes the supplier is wrongfully limiting supply. If Elite is unable to timely resolve this dispute in a reasonable manner then, unless and until Elite is able to obtain adequate amounts of API, it will not be able to sustain or grow the sales of the generic phentermine products. Elite has begun to qualify an alternative supplier, but qualification of an alternative supplier, due to FDA requirements, entails a significant amount of time and could be expected to take 12 months or longer.

 

A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

 

Item 9.01 Financial Statements and Exhibits

 

d) Exhibits

 

Exhibit No.   Exhibit
     
99.1   Press Release dated October 15, 2012

 

 
 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Dated: October 15, 2012

 

    ELITE PHARMACEUTICALS, INC.
     
  By: /s/ Chris Dick
  Name: Chris Dick
  Title: President & Chief Operating Officer