Aurobindo gets US FDA nod for 50mg dosage of HIV drug `Nevirapine'
26 Feb 2010
Aurobindo Pharma Ltd has received tentative approval from the US Food and Drug administration (US FDA) for its new drug application (NDA) Nevirapine 50mg oral suspension tablets.
"The NDA 22-299 provides for the use of Nevirapine tablets for oral suspension 50mg in combination with other antiretrovirals agents and is indicated for the treatment of HIV infections," Aurobindo said in a filing with the Bombay Stock Exchange (BSE).
Aurobindo Pharma recently received final approval for its Cetirizine Hydrochloride Solution 1mg/mL (OTC) from US FDA. This approval of is under over-the-counter (OTC) product category.
Cetirizine Hydrochloride Solution 1mg/mL is the generic equivalent of McNeil Consumer Healthcare Children's Zyrtec Oral Solution (Allergy), 1 mg/ml, and Children's Zyrtec Oral Solution (Hives Relief), 1 mg/ml.
Cetrizine Hydrochloride Solution is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children above 2 years of age and falls under the anti-allergic segment. Other indications include relief from itching due to hives. The product will be launched shortly, the company said in another release.
Aurobindo has received a total of 113 ANDA approvals (84 final approvals and 29 tentative approvals) from US FDA, the release said.
