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USFDA in Medical News

Lupin is Granted USFDA Approval for Levetiracetam Tablets

BALTIMORE, Jan. 16 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. (LPI) announced today that it has received final approval for the Company's Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets 250mg, 500mg, 750mg and 1000mg from the U.S. Food and Drug Administration (USFDA). Commercia...

Lupin Receives USFDA Approval for Divalproex Sodium Delayed-Release Tablets

BALTIMORE, July 31 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. (LPI) announced today that it has received final approval for the Company's Abbreviated New Drug Application (ANDA) for Divalproex Sodium Delayed-Release Tablets, 125 mg, 250 mg and 500 mg from the U.S. Food and Drug Administration...

Lupin Receives USFDA Approval for Escitalopram Oxalate Tablets

BALTIMORE, June 16 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. (LPI) announced today that it has received tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Escitalopram Oxalate Tablets 10 mg and 20 mg from the U.S. Food and Drug Administration (USFDA). Lupin's ...

Lupin Receives USFDA Approval for Topiramate Tablets

BALTIMORE, May 30 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. (LPI) announced today that it has received tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Topiramate tablets, 25 mg, 50 mg, 100 mg and 200 mg from the U.S. Food and Drug Administration (USFDA). Lu...

Aurobindo Gets USFDA Approval for A 3-Drug Combination Pack

The Hyderabad-based Aurobindo Pharma Ltd today said it has received the tentative new drug approval for a fixed drug combination product used for anti-HIV treatment. // The fixed drug compbination product contains Lamivudine 150mg+2idovudine300mg tablets co-packaged with Abacavir 300mg Tablet...

Lupin Gets USFDA Approval for Meloxicam

Lupin Ltd today said it has got the approval of US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Meloxicam tablets used in the treatment of osteoarthritis and rheumatoid arthritis. // The approval is for Meloxicam tablets of strengths of 7.5 mg and ...

Orchid Gets USFDA Nod for Cephalexin

Orchid Chemicals & Pharmaceuticals Ltd today said it has received approval from the USFDA for its ANDA (Abbreviated New Drug Application) of Cephalexin oral suspension. // Cephalexin, an off-patent molecule, forms part of Orchid Chemicals' distribution alliance with US generic pharma major Pa...

Aurobindo Gets USFDA Approval for Didanosine Chewable Tablets

Aurobindo Pharma Ltd today said it has received tentative approval by USFDA for its anti-HIV drug, Didanosine chewable tablets of 100mg, 150mg and 200mg strengths. // This is the first generic version approval for Didanosine chewable in the world given by USFDA, Aurobindo Pharma informed the ...

Aurobindo Gets Tentative USFDA Approval For Its HIV-1 Drug

Aurobindo Pharma today said it has recieved a tentative New Drug Approval from USFDA for its fixed dose combination product used for treating HIV-1 infection//. The new drug approval is for fixed dose combination drug product containing Lamivudine, Zidovudine, Nevirapine tablets used in the ...

Aurobindo Receives Approval from USFDA for anti-AIDS drug

AIDS patients, the world over, can heave a sigh of relief following the nod of approval from the US Food & Drug Administration// (FDA) for the world’s first anti-AIDS cocktail drug for use as a single dose. The drug manufacturer, Hyderabad-based bulk drugs major Aurobindo Pharma, has made combi...

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USFDA in Medical Technology

Immtech Reports Fiscal Second Quarter 2008 Results

... 30, 2007, several significant milestones were achieved. In addition to the Par Pharmaceutical agreement, Immtech received orphan drug status from the usfda for pafuramidine to treat malaria and African sleeping sickness, added a new board member and a strategic advisor to the team, and received from China...
USFDA in Biological Technology

Bio/Data Corporation Launches vW Select(TM) - The World's First and Only Complete Ristocetin CoFactor Assay

...asy to achieve and test results are consistent, reliable and available quickly. vW Select is manufactured, validated and performance tested under usfda Quality System Regulations as well as the ISO 13485:2003 (Medical Device) Quality Management System Standard. This simplifies test Implementation and ...

Glenmark's Novel Molecule for Diabetes, Melogliptin to Enter Phase III Trials

...nstrate potential for offering class leading improvements in glycemic control and metabolic function. Glenmark recently received IND approval from the usfda to carry out a clinical study in the US. Glenmark continues to be in discussions with various licensing partners to take the molecule forward. ...

The Pittsburgh Life Sciences Greenhouse Starts 2009 With Investment Momentum

... GAMP, etc. CaliberLIMS(TM) ensures regulatory compliance and increases quality output in the laboratory. About 90% of the current user companies are usfda certified pharmaceutical companies and CaliberLIMS(TM) has successfully passed through the FDA audits. Chronic Health Metrics is a disease manage...
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