FDA tentatively approves Lupin’s generic Topamax
WASHINGTON The Food and Drug Administration issued a tentative approval for Indian drug manufacturer Lupin’s application for a generic seizure medication on Friday, the company announced.
The company’s application covers 50mg, 100mg and 200mg tablets of the drug Topiramate, a generic equivalent to Johnson & Johnson’s Topamax, indicated for the treatment of epileptic seizures and migraines.
Based in Mumbai, India, Lupin specializes drugs for the treatment of drugs to treat tuberculosis, bacterial infections and cardiovascular disease. It has offices in the U.S., U.K., Russia, Uzbekistan, Kazakhstan and Thailand.
Sales of Topamax reached $1.8 billion in the first nine months of 2007, according to SEC filings. According to the Wall Street Journal, J&J’s patent for Topamax will expire Sept. 26. In March, a court in New Jersey upheld an injunction issued in 2006 preventing Canonsburg, Pa.-based Mylan Laboratories from marketing a generic equivalent to Topamax until the patent expires.
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.