Watson announces final FDA approval for generic Prilosec
CORONA, Calif. The Food and Drug Administration gave final approval Monday to Watson Pharmaceuticals for its application for omeprazole delayed-release capsules USP in 10 mg, 20 mg and 40 mg strengths, the company announced Monday.
The drug is a generic equivalent to AstraZeneca’s Prilosec and is for the short-term treatment of active duodenal ulcer. Being the first to file an application for the 40 mg strength, Watson will receive 180-day marketing exclusivity when the product launches in the third quarter of 2008. Watson will only launch the 40 mg strength.
Prilosec had worldwide sales of $1.143 billion in 2007, according to AstraZeneca’s annual report.
Juvaris tests flu vaccine addition
NEW YORK Burlingame, Calif.-based Juvaris BioTherapeutics is testing an adjuvant for flu vaccines.
JVRS-100, as the drug is known, is designed to augment vaccines by stimulating the immune system. Testing will involve 128 patients who will receive the drug ad an flu vaccine.
The trial will test the safety and tolerability of the drug.
Teva announces generic Wellbutrin XL and Zyrtec syrup
NORTH WALES, Pa. Teva Pharmaceuticals has announced the availability of two new generic drugs, Cetirizine hydrochloride syrup, the generic of Pfizer’s allergy medication Zyrtec syrup and Budeprion XL 150 mg, the generic of GlaxoSmithKline’s seasonal affective disorder medication Wellbutrin XL 150 mg.
Cetirizine Hydrochloride Syrup is available in a 5 mg/5 mL strength, in bottle sizes of 120 mL and 473 mL. Also, with the addition of this new strength, Teva now offers Budeprion XL tablets in 150 mg and 300 mg strengths, in bottle sizes of 30 and 500.
Zyrtec syrup has sales of $177 million in 2007 and Wellbutrin XL had sales of $992 million in 2007, according to drugs.com.