kareem
26-08-2003, Tue 4:16 PM
Andrx Corp - ADRX
Price 17.04
August 26, 2003 08:31
Andrx Gains FDA Tentative Approval for Generic 10 mg Glucotrol XL
FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Aug. 26, 2003--Andrx Corporation (Nasdaq:ADRX) today announced that the United States Food and Drug Administration ("FDA") has tentatively approved the Abbreviated New Drug Application ("ANDA") for its 10 mg glipizide extended release tablets, a bioequivalent version of Pfizer Inc.'s ("Pfizer") Glucotrol(R) XL tablets. Indicated for the treatment of Type II diabetes, the 10mg strength of Glucotrol XL had $217 million of brand sales in 2002, according to IMS data. The 30-month stay of FDA regulatory approval applicable to this ANDA will not expire until November 2003, and the patent infringement litigation pending between Andrx, Pfizer and Alza Corporation with respect to the three Glucotrol XL strengths for which Andrx has pending ANDAs is continuing. Andrx's ANDA for 5 mg and 2.5 mg Glucotrol XL was submitted after its ANDA for the 10mg strength, and has not been tentatively approved by the FDA. Though Andrx believes that it was the first to file an ANDA for 10 mg Glucotrol XL, the tentative approval letter issued by the FDA does not address the issues relating to the 180 day market exclusivity period for this product.
Price 17.04
August 26, 2003 08:31
Andrx Gains FDA Tentative Approval for Generic 10 mg Glucotrol XL
FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Aug. 26, 2003--Andrx Corporation (Nasdaq:ADRX) today announced that the United States Food and Drug Administration ("FDA") has tentatively approved the Abbreviated New Drug Application ("ANDA") for its 10 mg glipizide extended release tablets, a bioequivalent version of Pfizer Inc.'s ("Pfizer") Glucotrol(R) XL tablets. Indicated for the treatment of Type II diabetes, the 10mg strength of Glucotrol XL had $217 million of brand sales in 2002, according to IMS data. The 30-month stay of FDA regulatory approval applicable to this ANDA will not expire until November 2003, and the patent infringement litigation pending between Andrx, Pfizer and Alza Corporation with respect to the three Glucotrol XL strengths for which Andrx has pending ANDAs is continuing. Andrx's ANDA for 5 mg and 2.5 mg Glucotrol XL was submitted after its ANDA for the 10mg strength, and has not been tentatively approved by the FDA. Though Andrx believes that it was the first to file an ANDA for 10 mg Glucotrol XL, the tentative approval letter issued by the FDA does not address the issues relating to the 180 day market exclusivity period for this product.