FDA Approval: Pharmaceutical Formulations, Inc. Receives Final FDA Approval to Manufacture and Market Over-the-Counter Cimetidine (national brand equivalent Tagamet(R) HB(TM)200)
PR Newswire - June 22, 1998 11:04
EDISON, N.J., June 22 /PRNewswire/ -- Pharmaceutical Formulations, Inc. ("PFI")(OTC Bulletin Board: PHFR) announced that the Company received approval from the Food and Drug Administration of its abbreviated new drug application (ANDA) to manufacture and market OTC Cimetidine, the generic equivalent to SmithKline Beecham's brand, Tagamet(R) HB(TM)200.
PFI began shipping Cimetidine to its store brand (private label) customers immediately following the expiration of Tagamet's "market exclusivity" on Friday, June 19, 1998. Cimetidine (national brand equivalent Tagamet(R) HB(TM)200) is an acid reducer providing relief from heartburn, acid indigestion and sour stomach. The product will compete in the OTC $1.2 billion gastrointestinal category which features other brand names such as Zantac(R)75, Pepcid AC(R), Mylanta(R) and Maalox(R).
Charles E. LaRosa, President and Chief Executive Officer, said "We believe we are the only U.S.-based generic pharmaceutical company to receive FDA approval for this OTC drug. Its approval is fundamental to our business strategy to be a 'prime source' for drug development and manufacturing for our customers."
In anticipation of this product introduction, PFI has introduced a first in the store brand (private label) industry by producing an advertising program to support Cimetidine. The Company offered to its retail customers television and radio commercials which were customized to fit their marketplace positioning and advertising campaigns. According to Mr. LaRosa, "The advertising will help educate consumers to the availability of the product at retail and its comparability to the Brand in safety and efficacy. It not only allows us to introduce a major new product for our customers, but also adds to their efforts in building equity in their store brand name."
PFI is the second largest solid dosage OTC generic pharmaceutical manufacturer in the country, offering more than 120 different types of over-the-counter products in tablet, caplet and capsule form including analgesics, cough/cold preparations, sinus/allergy and gastrointestinal relief products. In addition, the Company also sells and markets a line of antifungal aerosols.
This press release may contain forward-looking information and should be read in conjunction with the Company's Form 10-K for the year ended June 30, 1997 and subsequent SEC filings.
Tagamet(R)/HB(TM), Zantac(R)75, Pepcid AC(R), Mylanta(R) and Maalox(R) are registered trademarks of companies unrelated to PFI.
SOURCE Pharmaceutical Formulations, Inc.
/CONTACT: Richard Jay Coyle of Bentley Partners, 800-891-7782, for
Pharmaceutical Formulations/
|
