Indian firm Strides Acrolab gets FDA nod for generic cancer drug

Indian drug firm Strides Arcolab announced it had received approval from the USFDA for the its generic Fluorouracil Injection which will be used to treat various types of cancer. The company’s wholly-owned subsidiary Onco Therapies Ltd has received two approvals from the United States Food and Drug Administration for its abbreviated new drug applications (ANDA) for Fluorouracil Injection USP in two strengths. 
The approvals are for the injection in the strengths of 50 mg / ml, packaged in 10 ml and 20 ml single-dose vials and 2.5 g/ 50 ml and 5 g / 100 ml pharmacy bulk packages, it added. Fluorouracil is among the products in the drug shortage list of USFDA and according to IMS data, the US market for generic Fluorouracil is nearly $14 million.
http://health.india.com/news/indian-firm-strides-acrolab-gets-fda-nod-for-generic-cancer-drug/

India to give free generic drugs to hundreds of millions

• India has put in place a $5.4-billion policy to provide free generic medicine to patients, vastly expanding access to drugs in the country, as reported Thursday in The Asahi Shimbun.
• Under the plan, doctors will be limited to a generics-only drug list and face punishment for prescribing branded medicines, and the government expects that within five years, up to half of India's 1.2 billion people are likely to take advantage of the scheme.
• "The policy of the government is to promote greater and rational use of generic medicines that are of standard quality," said L.C. Goyal, additional secretary at India's Ministry of Health and Family Welfare, adding that "they are much, much cheaper than the branded ones."
• Chris Stirling of KPMG said that "pharmaceutical firms will likely rethink their emerging markets strategies carefully to take account of this development, and any similar copycat moves across other geographies."
• "Without a doubt, it is a considerable blow to an already beleaguered industry, recently the subject of several disadvantageous decisions in India," Stirling added.
• However, he noted that "the move will please the generics manufacturers who stand to gain substantially in competing for contracts."

http://www.firstwordpharma.com/node/999234

Dr Reddy's launches Parkinson's drug in US

Dr. Reddy's has obtained the approval of the United States Food and Drug Administration ( USFDA) for its abbreviated new drug application for Ropinirole Hydrochloride XR tablets to launch generic product.Ropinirole Hydrochloride XR tablets are bioequivalent generic version of Requip XL tablets, a registered trademark of pharma giant SmithKline Beecham.
Requip XL had reported sales of around $58 million for the 12 months period ended March 2012 in the US market according to IMS Health.
Dr Reddy's said its Ropinirole Hydrochloride XR tablets in 2 mg, 4 mg and 6 mg will be available in 30 and 90 count bottle sizes, 8 mg and 12 mg in 30 count bottle sizes.
http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/pharmaceuticals/dr-reddys-launches-parkinsons-drug-in-us/articleshow/13894089.cms