FDA gives Hi-Tech Pharmacal approval for generic Hycodan

AMITYVILLE, N.Y. Hi-Tech Pharmacal Co. announced that the Food and Drug Administration has granted an approval to the company’s application for hydrocodone bitartrate and homatropine methylbromide syrup, the generic equivalent of Endo Pharmaceuticals’ Hycodan. Hydrocodone bitartrate and homatropine methylbromide syrup is indicated for symptomatic cough relief.

Hi-Tech specializes in difficult-to-manufacture liquid and semi-solid dosage forms of generic medications and produces a range of sterile ophthalmic, otic and inhalation products.

Hydrocodone bitartrate and homatropine methylbromide syrup had sales of approximately $5 million for 2006, according to IMS Health data. Hi-Tech expects to start marketing the product immediately.