Separately, Andrx has received approval for loratadine/pseudoephedrine
sulfate, the generic equivalent to Schering-Plough Corp.
In this double-blind, placebo-controlled, crossover, parallel study, we treated 20 adults who had seasonal allergic rhinitis with once-daily fixed-combination loratadine/pseudoephedrine sulfate to observe its effect on relieving symptoms, primarily nasal congestion.
The goal of this study was to further evaluate the efficacy of loratadine/pseudoephedrine in relieving nasal congestion in patients with seasonal allergic rhinitis, and to assess by several different measures of effectiveness its effect on other common parameters associated with allergic rhinitis.
We undertook this double-blind, placebo-controlled, crossover, parallel trial at the University of Chicago to study the effect of loratadine/pseudoephedrine on nasal congestion caused by natural exposure to seasonal allergens in patients who had seasonal allergic rhinitis.
The company, which hopes to begin shipping the items by the middle of the year, will offer 5/120 mg and 10/240 mg loratadine/pseudoephedrine
tablets as well as loratadine rapid-disintegration tablets.
Andrx Corporation (Nasdaq:ADRX) today announced that is has entered into a settlement with Schering-Plough Corporation resolving patent litigation regarding Andrx's Loratadine/Pseudoephedrine
10mg/240mg product, which is a bioequivalent version of Schering-Plough's Claritin-D(R) 24 Hour Extended Release Tablets ("Claritin-D 24").
Andrx Corporation (Nasdaq:ADRX) today announced that its loratadine/pseudoephedrine
10mg/240mg product, that is bioequivalent to Schering-Plough's Claritin-D(R) 24 Hour Extended Release Tablets ("Claritin-D 24"), has been launched by its marketing partner, L.
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).
Andrx Corporation (Nasdaq:ADRX) and Perrigo Company (Nasdaq:PRGO) today announced that they have entered into a multi-year agreement whereby Andrx will manufacture and supply Perrigo with loratadine/pseudoephedrine
5/120 mg, loratadine rapidly-disintegrating and loratadine/pseudoephedrine
10/240 mg (generic versions of Claritin-D(R) 12 Hour, Claritin RediTabs(R) and Claritin-D(R) 24 Hour, respectively), which Perrigo will market as over-the-counter (OTC) products.
Food and Drug Administration (FDA), included: Loratadine/Pseudoephedrine
Sulfate 12 hour Extended Release Tablets (generic of Claritin(R) D12), Loratadine/Pseudoephedrine
Sulfate 24 hour Extended Release Tablets (generic of Claritin(R) D24), Loratadine Orally Disintegrating Tablets (generic of Claritin(R) Reditabs), Bupropion Extended Release Tablets (generic of Wellbutrin(R) SR Tablets), Bupropion Extended Release Tablets (generic of Zyban(R) Tablets) and Omeprazole Delayed Release Capsules (generic of Prilosec(R) Capsules).
In addition, we signed two significant agreements last quarter: one regarding the loratadine/pseudoephedrine
sulfate products for the OTC market with Wyeth; and the second one, a Manufacturing and Supply Agreement with Schering relating to Claritin D(R) 12-Hour for the OTC market.
Both of the Company's Abbreviated New Drug Applications (ANDAs) for Loratadine/Pseudoephedrine
Sulfate Extended Release Tablets have previously been granted tentative approval by the U.