Page 47 - IACC Newsletter March 2013 Issue no. 9

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Indo-US Corporate News
Aurobindo Pharma gets tentative nod from US health regulator for anti-AIDS drug
Drug firm Aurobindo Pharma today said it has received tentative approval from the US health regulator to manufacture
and market its anti-AIDS combination drug Efavirenz/Emtricitabine and Tenofovir Disoproxil Fumarate tablets in the
American market.
The company has received tentative approval from the US Food and Drug Administration (USFDA) for the combination
drug in the strength of 600mg/200mg/300mg Aurobindo Pharma said in a statement.
The tablets are generic equivalent of Gilead Sciences Inc.’s Atripla tablets in the same strength combination and fall
under the anti-retroviral (ARV) segment, it added. "It is indicated in combination with other antiretroviral agents for the
treatment of HIV-1 infection in adults. This ANDA (abbreviated new drug application) was reviewed under the expedited
provisions of the President's Emergency Plan for AIDS relief (PEPFAR)," Aurobindo said.
The company now has a total of 182 abbreviated new drug application (ANDA) approvals (156 final approvals, including
two from Aurolife Pharma LLC and 26 tentative approvals) from USFDA, it added.
Dr Reddy's launches generic Zoledronic Acid injection in US
Drug firm Dr Reddy's Laboratories today said it has launched generic Zoledronic Acid injection used for treating
osteoporosis and Paget's disease of bone in the US market following approval from the US health regulator.
The company has launched Zoledronic Acid injection (5 mg/ 100 mL) yesterday, following approval of its abbreviated
new drug application (ANDA) by the US Food & Drug Administration (USFDA), Dr Reddy's Laboratories said in a
statement.
The product is generic version of Novartis AG's Reclast injection in the same strength, it added. "The Reclast brand had
total US sales of approximately $355 million for the most recent twelve months ending February, 2013 according to IMS
Health," Dr Reddy's said.
The company's Zoledronic Acid injection is available in a single use vial for intravenous infusion, it added. Paget's disease
of bone is a chronic disorder that can result in enlarged and misshapen bones.
Boeing, Pfizer & Dow among US entities lobbying on India issues
At least a dozen US-based entities, including giants like Boeing, Pfizer, Dow Chemicals and Morgan Stanley, have
indulged in lobbying among the American lawmakers here regarding India-related trade issues since the beginning of
this year. The companies having lobbied with the US lawmakers on trade and other issues related to India during the
first quarter of 2013 also include Corning Inc., Duke Energy and Applied Materials Inc., show the latest Congressional
records of lobbying disclosure filings here.
Besides, industry bodies like Telecommunications Industry Association, Aerospace Industries Association of India,
Pharma (which represents leading research-based pharmaceutical and biotechnology companies in the US), National
Association of Manufacturers and National Electrical Manufacturers Association also lobbied on India-related issues.