Japanese regulator PMDA completes inspection of Lupin Mandideep facility unit, no major observations Medical Dialogues Bureau6 Jun 2019 2:05 PM ISTNew Delhi: Drug firm Lupin Tuesday said Japanese regulatory agency, PMDA, has concluded the inspection of Unit 2 at Mandideep facility in Madhya...
Eli Lilly Bags USFDA nod for its migraine drug as first ever cluster headache treatment Medical Dialogues Bureau6 Jun 2019 1:27 PM ISTNEW YORK: Eli Lilly and Co's migraine treatment Emgality on Tuesday became the first drug to gain U.S. approval for decreasing the frequency of...
CDSCO releases updated list of 2006 WHO GMP certified drug manufacturers; Details Farhat Nasim6 Jun 2019 12:11 PM ISTNew Delhi: The apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has recently released an updated list of WHO GMP...
Mallinckrodt to settle U.S. drug marketing probe, fight kickback case Medical Dialogues Bureau6 Jun 2019 9:22 AM ISTMallinckrodt Plc on Wednesday said it had tentatively agreed to pay $15.4 million to resolve a U.S. Justice Department probe into how a drugmaker it...
India calls for expanding antiretroviral therapy coverage to combat HIV/AIDS Farhat Nasim6 Jun 2019 9:22 AM ISTIn India, a landmark HIV and AIDS (Prevention and Control) Act came into force from September 10 last year that provides a rights-based framework to...
Aurobindo Pharma gets 10 observations from USFDA for its Unit 3 at Hyderabad Medical Dialogues Bureau5 Jun 2019 12:28 PM ISTNew Delhi: Drug firm Aurobindo Pharma Tuesday said it has received 10 observations from the US health regulator for its Unit 3 in Hyderabad.The United...
Swiss company Actelion moves US court against Natco Pharma over generic of its patented drug Medical Dialogues Bureau5 Jun 2019 12:27 PM ISTHyderabad: Swiss pharma company Actelion Pharmaceuticals Ltd has filed a petition in a US court alleging that Natco Pharma and its US partner Syneos...
Natco Pharma files ANDA for generic version of Bosentan tablets for oral suspension Farhat Nasim5 Jun 2019 10:00 AM ISTBosentan 32 mg tablets are sold by Actelion Pharmaceuticals US, Inc. (acquired by Johnson and Johnson) under the brand name Tracleer.Hyderabad:...
NPPA fixes retail price of 18 commonly used formulations including Metformin, Atorvastatin; Details Farhat Nasim4 Jun 2019 5:44 PM ISTNew Delhi: Through a recent notification, the government regulatory agency, the National Pharmaceutical Pricing Authority (NPPA) has fixed the retail...
Dr Reddys Labs relaunches Zenatane-generic version of Accutane in US Farhat Nasim4 Jun 2019 11:52 AM ISTZenatane (lsotretinoin Capsules, USP), 10 mg, 20 mg, 30 mg and 40 mg is being launched with an approved Risk Evaluation and Mitigation Strategy (REMS)...
Merck wins USFDA approval for antibiotic Zerbaxa to treat pneumonia Medical Dialogues Bureau4 Jun 2019 9:50 AM ISTThe approval is based on the treatment's late-stage trial results, which showed that Merck's drug, Zerbaxa, was as effective as another antibacterial...
Domestic growth helped Indian pharma companies offset pricing pressure in US: Fitch Medical Dialogues Bureau4 Jun 2019 9:30 AM ISTMany of the leading pharma companies reported double-digit growth in their domestic sales which in turn supported overall industry growth of 11 per...
