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...

Ranbaxy Gets USFDA Nod For Simvastatin

Pharma major Ranbaxy Laboratories Ltd has received approval from the USFDA for manufacturing and marketing cholesterol-lowering Simvastatin Tablets in the US market. // The company said it has received the approval for marketing the drug in strengths of 80mg with 180 day exclusivity. Si...

Lupin Gets USFDA Approval For Quinapril Tablets

Pharmaceutical company Lupin Ltd today said it has recieved the final approval from USFDA to market its Abbreviated New Drug Application (ANDA) of hypertension medicine Quinapril in US. // The company informed the Bombay Stock Exchange that the approval is for the multiple dosages of strength...

Cadila Gets Tentative USFDA Nod For Pravastatin Sodium Tablets

Cadila Healthcare Ltd has received tentative approval from the USFDA to market Pravastatin Sodium Tablets in the US market. // The tentative approval was given for strengths of 10 mg, 20 mg, 40 mg and 80 mg, the company informed the Bombay Stock Exchange. The company would market the dru...

Ranbaxy Gets USFDA Approval For Doxycycline Tablets

Ranbaxy Laboratories Ltd has received approval from USFDA for manufacturing and marketing Doxycycline Tablets in the US market.// The company informed the Bombay Stock Exchange that it got the approval for marketing the antibiotic in strengths of 50mg, 75mg and 100mg. Doxycycline is indi...

Morepan to file new drug applications with the USFDA

Domestic pharma major Morepen Labs is planning to file its nine abbreviated new drug applications (ANDA) with the US FDA by the year 2003. The company would file its first two ANDAs - Loratadine (anthistatminic drug) and Atorvastain Calcium (anti-cholesterol) - by the end of 2002. Loratadine is the...

DIA 45th Annual Meeting Features Sessions Highlighting Wyeth v. Levine and Pandemic Influenza

...IO, United States. Speakers include:   Jean L Hu-Primmer, MS, Program Manager, Pandemic and Emerging Threat Preparedness, OD, CBER, usfda John Purves, PhD, Head of Sector, Quality of Medicines, European Medicines Agency Ozzie Berger, Senior Director and Head, Influenza Vaccines, U...

DRAXIMAGE(R)'s generic Sestamibi Approved for launch in USA

...Co-Chairman of Jubilant Organosys said: "We are very excited to receive the usfda approval of one of our key radiopharma products which strengthens our posit...ate price erosion for this product." The DRAXIMAGE(R)'s generic Sestamibi usfda approval is a significant milestone for the Company's radiopharma business....

New Cardiovascular and Orthopaedic Content Pushes Materials for Medical Devices Database to Milestone

... used in medical devices. The database also draws references from 3,700 sources including journal articles, conference proceedings, manufacturer data, usfda CDRH 510K submissions, PMAs, SSEDs and FDA standards and guidance documents. Comprehensive reviews of the literature concerning biocompatibility o...

Materials for Medical Devices Database Reaches Milestone

... used in medical devices. The database also draws references from 3,000 sources including journal articles, conference proceedings, manufacturer data, usfda CDRH 510K submissions, PMAs, SSEDs and FDA standards and guidance documents. Comprehensive reviews of the literature concerning biocompatibility ...

Agreement Executed for Amneal Pharmaceuticals to Acquire the Assets of Interpharm Holdings

...Weiss, Interpharm's executive vice president of sales and marketing. Amneal will list assets of over one hundred products approved or filed with the usfda and in development, controlled substance (C II-V) licensing and manufacturing, hormonal production suite, high potency production suite, soft gelatin ...

Study suggests antibiotic may prevent dreaded brain fever

...ated official figure for JE cases in India, a rough estimate would indicate a few thousands fatalities every year. The team found that minocycline, an usfda approved drug, often used to treat acne, limits the death by reducing the microglial activation, neuronal death as well as viral replication. Microgli...

MedWaves, Inc. Announces Receipt of United States Food and Drug Administration 510k Clearance to Market Its Patented Microwave Coagulation/Ablation System

... SAN DIEGO, Jan. 31 /PRNewswire/ -- MedWaves, Inc. announces the receipt of usfda 510k clearance to market its patented Microwave Coagulation/Ablation System...expansion of a product portfolio and indications for use through additional usfda submissions and clearances. The Company's proprietary technology allows for...

POLY Medicure Ltd Applies for 8 Patents, 2 FDA Approvals

... Poly Medicure Ltd today said it has applied for eight new patents and two usfda approvals for its new range of safety syringes and safe blood collection holders. // "In our latest safety syringe, the needle retracts back in ...

Aurobindo Pharma Purchases US Manufacturing Facility

... The Hyderabad-based Aurobindo Pharma Ltd today said it has acquired a usfda compliant manufacturing facility in Dayton, New Jersey//. The facility, spread over 20 acres of freehold land, will serve as the company's US hea...

Ranbaxy's Four HIV/AIDS Drugs In WHO Pre-Qualification List

...r Mohan Singh said. With these inclusions, Ranbaxy now has a total of 12 ARVs on the WHO pre-qualification list. It also has three approvals from usfda for ARVs, making it eligible for supplying to the US funded PEPFAR programme. "Efavirenz is rapidly becoming a preferred drug in HIV treatment pr...

Indian Pharmaceutical Industries Stops Manufacturing And Sale Of Valdecoxib

... Indian Pharmaceuticals companies Glenmark pharma and Nicholas Piramal has withdrawn their drug Valdecoxib from the Indian market after usfda ban the sale of Valdecoxib formulation products and the recent notification issued by // the health ministry of the government of India asking the pha...