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 third-largest selling drug in the world. ....Currently, Morepen’s ANDAs pipeline has Loratadine, Fe...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 indicated for a variety of infections caused by susceptible strains or micro-organisms including respirato...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 drug through its US subsidiary Zydus Pharmaceuticals (USA) Inc, following patent expiry, it added... ..Th...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 strengths 5 mg, 10 mg, 20 mg and 40 mg. .. ..Quinapril is a AB-rated generic equivalent of Pfizer's hypertens...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. .. ..Simvastatin, currently marketed as 'Zocor' in the US, has been found to be bioequivalent by the FDA Offi...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 combined anti-retro virals (ARVs) — Retrovir (zidovudine), Epivir (lamivudine) and Viramune (nevirapine) i...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 treatment of HIV-1 infection, the company informed the Bombay Stock Exchange... ..The three drugs wou...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 Bombay Stock Exchange... ..The aforesaid product would now be available for purchase under the Presid...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 Par Pharmaceuticals Inc, it informed the Bombay Stock Exchange... ..Orchid added that its Cephalexin ca...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 15 mg , the company informed the Bombay Stock Exchange... .."The approval of our Meloxicam ANDA furth...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 Tablets, the company informed the Bombay Stock Exchange. ....This combination pack enhances convenience, is...