Strides Arcolab unit gets USFDA nod for cancer injection

Bangalore: Onco Therapies, a subsidiary of Strides Arcolab, has received US Food and Drug Administration (FDA) approvals for anti-cancer Cisplatin injection.

The company's shares on the BSE rose slightly over 3 per cent to close at Rs 653 a share following the announcement.

Cisplatin is a chemotherapy drug and is used to treat various types of cancers, including sarcomas, some carcinomas (example small cell lung cancer, and ovarian cancer), lymphomas, and germ cell tumours. The company in a release said approvals is for Cisplatin injection of one mg/ml packages in 50 ml and 100 ml multiple dose vials.

It is amongst the products in the drug shortage list of USFDA. According to the IMS data, the US market for generic Cisplatin is about $10 million.

New Delhi: Strides Arcolab has received US-FDA approval for Vancomycin hydrochloride antibiotic capsules, used to treat bacterial infections. Shares of the company rose slightly over 6 per cent to close at Rs 631.90 following the announcement.

Vancomycin antibiotic capsules are used in the prophylaxis and treatment of infections caused by gram-positive bacteria. The drug has traditionally been reserved as a ‘last resort' remedy, used only after treatment with other antibiotics fails.

Mr Arun Kumar, Group CEO of Strides, in a statement, said: “Oral Vancomycin development is one among the many generics programmes being undertaken at the Strides group, with a special focus to develop niche and difficult to manufacture products.”

The product will be launched immediately through Alvogen, a US-based privately-owned pharmaceuticals company, on a profit share basis.

According to IMS health data, Vancomycin capsules had total US sales of $332 million for the 12 months ending February 2012, with no prior generic approvals.