 "Aurobindo Pharma gets USFDA nod for antibiotic drug")
The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Vancomycin Hydrochloride for Injection USP (Pharmacy Bulk Package), Aurobindo Pharma said in a regulatory filing.
Read more from our special coverage on "AUROBINDO PHARMA"
- Aurobindo Pharma gets FDA nod for Alzheimers, Parkinsons drug
- Aurobindo Pharma gains on USFDA nod for Naproxen Sodium Tablets
- Aurobindo Pharma gets final nod for osteoporosis drug
- Aurobindo gets USFDA nod for antidote to pain-killer drug overdose
- Aurobindo Pharma surges on USFDA nod for anti-HIV tablets
"This product is expected to be launched in the later part of FY16-17," it added.
The company's product is the generic version of US-based Fresenius Kabi's Vancomycin Hydrochloride for Injection USP. It is an antibiotic used in the treatment of severe infections.
"The approved product has an estimated market size of $160 million for the twelve months ending January 2016 according to IMS," the company said.
The Hyderabad-based firm now has a total of 247 Abbreviated New Drug Application (ANDA) approvals from the USFDA.
Shares of Aurobindo Pharma were trading 1.44% up at Rs 746 apiece during afternoon session on the BSE.