Tavist Allergy/Sinus/Headache is the only over-the-counter medication to combine the antihistamine clemastine fumarate
with a nasal decongestant and pain reliever.
5 /PRNewswire/ -- The Perrigo Company (Nasdaq-NNM: PRGO) announced today that it has received approval from the Food & Drug Administration (FDA) to manufacture Clemastine Fumarate Tablets USP, 1.
The FDA concluded that Clemastine Fumarate produced by Perrigo was safe, effective and bioequivalent to the original drug produced by Sandoz Pharmaceuticals Corporation.
The company's lingual spray formulation of clemastine fumarate, the active ingredient in Tavist(R)(a), is being developed for the rapid treatment of hay fever symptoms.
The company's clemastine fumarate lingual spray is expected to be one-half of the OTC dose, or 0.
As a result of the exclusive agreement, Perrigo will manufacture and distribute tablets to its store brand customers that will contain the active ingredients clemastine fumarate
USP, an antihistamine, and phenylpropanolamine HCI USP, a nasal decongestant.
The FDA decision results from well-controlled clinical studies of the antihistamine clemastine fumarate, the active ingredient that differentiates the Tavist products from others.
After reviewing the findings of two well-controlled clinical studies plus several supporting studies, in November 1995 an FDA Advisory Panel unanimously recommended that the Tavist products, with the antihistamine clemastine fumarate, be recognized by the FDA as effective in treating cold symptoms, including sneezing and runny nose.
Pharmaceuticals group has received ANDA approvals from the Food and Drug Administration to manufacture and market three new products: Miconazole Nitrate Vaginal Suppository 100 mg, Miconazole Nitrate Vaginal Suppository 200 mg, and Clemastine Fumarate Syrup .
The approval for Clemastine Fumarate Syrup, received by the Company's Barre-National subsidiary, is the generic equivalent to the branded product, Tavist, which has annual sales of more than $24 million.
Currently, the only major brand which contains the ingredient clemastine fumarate is Tavist-D and Tavist-1.
Results showed the clemastine fumarate reduced runny noses and sneezing by up to 50 percent over the study group using the placebo.