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Andrx Receives Approvals for Generic Claritin-D 24 and Nolvadex
FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Feb. 24, 2003--Andrx Corporation (Nasdaq:ADRX) today announced that the United States Food and Drug Administration ("FDA") has approved the marketing of its Abbreviated New Drug Applications ("ANDA") for its bioequivalent of Schering-Plough's Claritin-D(R) 24 Hour Extended Release Tablets ("Claritin-D 24"), with a 180-day period of exclusivity, and for its 10 mg and 20 mg generic equivalents of AstraZeneca's Nolvadex(R) tablets.
Claritin-D 24 is Loratadine/Pseudoephedrine Sulfate 10mg/240mg extended-release tablets, a once daily decongestant used to relieve symptoms of seasonal allergic rhinitis (commonly known as hay fever). Though Claritin-D 24 had 2002 U.S. prescription sales of approximately $480 million, in November 2002, the FDA approved the use of this and the other Claritin line of products, at their original prescription strengths, as over-the-counter (OTC) medicines. In response to this development, Andrx entered into its previously announced agreement with Perrigo Company, the nation's largest provider of store brand over-the-counter pharmaceuticals, for Perrigo to market Andrx's bioequivalent versions of Claritin products (Claritin-D 24, and when approved, Claritin-D(R) 12 and Claritin Reditabs(R)) as OTC products. Andrx anticipates that Perrigo's first shipments of Claritin-D 24 will begin by mid-2003.
Nolvadex is Tamoxifen Citrate, used in the treatment of breast cancer, which had 2002 U.S. brand and generic sales totaling approximately $500 million. With the expiration of pediatric exclusivity, numerous generic competitors have already entered the market at the same time, which has resulted in substantial pricing erosion. Rather than launching its tamoxifen citrate product, Andrx is both preparing itself for other more significant launch opportunities, including the Claritin family of products, and working to remedy the issues relating to its manufacturing capacity constraints and inefficiencies.
Andrx Receives Approvals for Generic Claritin-D 24 and Nolvadex
FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Feb. 24, 2003--Andrx Corporation (Nasdaq:ADRX) today announced that the United States Food and Drug Administration ("FDA") has approved the marketing of its Abbreviated New Drug Applications ("ANDA") for its bioequivalent of Schering-Plough's Claritin-D(R) 24 Hour Extended Release Tablets ("Claritin-D 24"), with a 180-day period of exclusivity, and for its 10 mg and 20 mg generic equivalents of AstraZeneca's Nolvadex(R) tablets.
Claritin-D 24 is Loratadine/Pseudoephedrine Sulfate 10mg/240mg extended-release tablets, a once daily decongestant used to relieve symptoms of seasonal allergic rhinitis (commonly known as hay fever). Though Claritin-D 24 had 2002 U.S. prescription sales of approximately $480 million, in November 2002, the FDA approved the use of this and the other Claritin line of products, at their original prescription strengths, as over-the-counter (OTC) medicines. In response to this development, Andrx entered into its previously announced agreement with Perrigo Company, the nation's largest provider of store brand over-the-counter pharmaceuticals, for Perrigo to market Andrx's bioequivalent versions of Claritin products (Claritin-D 24, and when approved, Claritin-D(R) 12 and Claritin Reditabs(R)) as OTC products. Andrx anticipates that Perrigo's first shipments of Claritin-D 24 will begin by mid-2003.
Nolvadex is Tamoxifen Citrate, used in the treatment of breast cancer, which had 2002 U.S. brand and generic sales totaling approximately $500 million. With the expiration of pediatric exclusivity, numerous generic competitors have already entered the market at the same time, which has resulted in substantial pricing erosion. Rather than launching its tamoxifen citrate product, Andrx is both preparing itself for other more significant launch opportunities, including the Claritin family of products, and working to remedy the issues relating to its manufacturing capacity constraints and inefficiencies.
