Aurobindo gets US FDA nod for 50mg dosage of HIV drug `Nevirapine'

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.