Roxane Laboratories has received approval of its Abbreviated New Drug Application (ANDA) for Anastrozole Tablets, 1mg by the FDA. The product is available in bottles of 30 for immediate shipment to wholesalers and pharmacies across the US. Roxane Laboratories’ Anastrozole Tablets are AB rated to ARIMIDEX® (anastrozole) tablets.

Unichem Lab has received Abbreviated New Drug Abbreviation (ANDA) approval from the US FDA for clonidine hydrochloride tablets. Clonidine Hydrochloride is a low dose potent and popular molecule in the antihypertensive category. Clonidine hydrochloride tablets USP 0.1mg, 0.2mg and 0.3mg are therapeutically equivalent to Catapres tablets USP 0.1mg, 0.2mg and 0.3mg from Boehringer Ingelheim. Clonidine hydrochloride formulations have annual sales of roughly $334 million in the US.

Glenmark Generics Inc and partner InvaGen has got the Abbreviated New Drug Application (ANDA) approval from the FDA for Fosinopril Sodium and Hydrochlorothiazide tablet to be used for the treatment of hypertension. Fosinopril Sodium and Hydrochlorothiazide(HCTZ) tablets are available in both 10mg/12.5mg and 20mg/12.5mg strengths. While Glenmark would exclusively market and distribute the product in the US, InvaGen would manufacture and supply the drug.

Barr Pharmaceuticals Inc. announced that its subsidiary, Barr Laboratories Inc., has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) to manufacture and market a generic version of Yasmin (drospirenone and ethinyl estradiol). Yasmin is an oral contraceptive product manufactured and marketed by Bayer Schering Pharma AG.

Teva Pharmaceutical Industries Ltd. has received tentative FDA approval for its ANDA (abbreviated new drug application) to market a gastric-acid pump inhibitor. Teva is currently in patent dispute litigation over the product, which is a generic form of TAP Pharmaceutical’s drug Prevacid (Lansoprazole) Delayed-release Capsules, 15 mg and 30 mg.