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.
FDA approves two new APP generic medications
SCHAUMBURG, Ill. The Food and Drug Administration approved APP Pharmaceuticals’ new drug applications for caffeine citrate oral solution at 20 milligrams/milliliter and for bleomycin sulfate for injection.
Caffeine citrate oral solution, the generic version of Bedford Labs’ Cafcin, is a treatment used for premature infants who have apnea, a condition where babies stop breathing during sleep for a brief amount of time, according to published reports.
Bleomycin is a treatment for cancer, a generic of Bristol-Myer’s Blenoxane, although it works in combination with other medicines. As a result of the recent FDA approval, APP Pharma stock increased to $10.33, a three-cent increase per share.
Shares of Labopharm rise with positive Trazodone study
NEW YORK Positive results on Trazodone, a once-daily anti-depressant pill, caused shares of Labopharm to rise on Friday.
According to published reports, Trazodone is a pill whose main goal is to improve a patient’s quality of sleep. The study reveals that this goal was met, with 412 patients showing that a once-daily version is effective and also inhibits a patient from awaking as frequently during the night.
The stock for Labopharm rose by 18.7 percent, about 37 cents, increasing the stock price to $2.35 in morning trading. Over the past year, the stock has ranged between 63 cents and $7.21.
The Food And Drug Administration already approved the twice-daily version of Trazodone, and Labopharm is planning to file a new drug application for its newest version of Trazodone with the FDA later in the year.