Impax Announces Otc Alliance With Wyeth

impax-laboratories Inc., which has recently won tentative approval from the FDA for a generic version of Claritin tablets, has signed a “semi-exclusive” development, license and supply agreement with Wyeth for this drug. Claritin is marketed by Corp. for the relief of symptoms of seasonal allergic rhinitis, or hay fever.

Worldwide sales of the drug reached $3.2 billion in 2001.

Claritin is currently a prescription drug in the U.S., but has filed an application to make it available over the counter.

Impax said the agreement with Wyeth relates to Impax’s generic version of Claritin-D 12-Hour and Claritin-D 24-Hour extended release tablets for the over-the-counter drug market.

Impax said that final approval from the FDA for its generic version of Claritin is subject to the resolution of a patent infringement lawsuit filed by against Impax or the expiration of the 30-month stay process under the Hatch-Waxman Act amendments.


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