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.

Lundbeck Inc has received approval from the FDA for its two New Drug Applications (NDA), Sabril (vigabatrin) Tablets and Oral Solution. Lundbeck will be launching Sabril in the US during the third quarter. Sabril is indicated as a monotherapy for pediatric patients, aged between one month and two years, with infantile spasms for whom the potential benefits outweigh the potential risk of vision loss. The drug is also indicated as an add-on therapy for adult patients with refractory complex partial seizures who have failed other available treatments and for whom the potential benefits outweigh the risk of vision loss.

The FDA has approved Onglyza, a once-daily treatment for type 2 diabetes to be taken in combination with diet and exercise. Onglyza, manufactured by Bristol-Myers Squibb, was tested in diabetes patients at relatively low risk of heart disease. The FDA approval requires Bristol-Myers Squibb to conduct a postmarketing study to evaluate the drug’s heart safety in higher-risk patients.

Watson Pharmaceuticals has received FDA approval for a generic version of the high blood pressure and angina drug Toprol XL. Watson Pharma expects to starts shipping the metoprolol drug immediately. The drug would be available in 25 mg and 50 mg extended-release tablets. According to Watson Pharma, the US sales of Toprol XL and generic equivalents totaled $628 million for the year ended June 30, 2009.

Hospira has obtained approval for its anti-infective Azithromycin injection from the FDA. Azithromycin is a generic variant of Pfizer’s Zithromax and is ADD-Vantage system compatible. ADD-Vantage is an advanced drug delivery system that does not need a needle and syringe to mix the drug with the solution. This lowers the risk of accidental needle pricks, improves workflow and prevents waste due to stability and shelf-life elements.