FDC Rationality: Now 6 months accelerated stability study data to be submitted, directs DCGI Meghna A Singhania27 March 2019 4:48 PM ISTNew Delhi: Manufacturers of Fixed Dose Combinations drugs ( FDC drugs) which have declared rational and approved by Drugs Controller General India...
Sandoz launches generic Treprostinil Injection Farhat Nasim27 March 2019 4:05 PM ISTSandoz will collaborate with RareGen, LLC to commercialize Treprostinil Injection, which is supplied in 20 mL multi-dose vials in four strengths –...
AstraZeneca gets EU nod to diabetes drug Forxiga Medical Dialogues Bureau27 March 2019 2:55 PM ISTFarxiga or Forxiga, as the drug is known outside the United States, is one of AstraZeneca's top ten drugs by sales. It generated $1.39 billion in 2018...
Alembic Pharma gets USFDA nod to Tadalafil tablets for treating erectile dysfunction Farhat Nasim27 March 2019 1:49 PM ISTThe approved product, Tadalafil tablets, is generic version of Eli Lilly and Company's Cialis tablet. New Delhi: Drug firm Alembic Pharmaceuticals...
USFDA approves Novartis' oral drug Mayzent to treat multiple sclerosis Farhat Nasim27 March 2019 12:58 PM ISTMayzent is a synthetic derivative of Gilenya that has a similar way of working but which Novartis has modified to try to reduce side effects like a...
JnJ, Bayer settles Xarelto lawsuits for 775 million Dollar Farhat Nasim27 March 2019 12:24 PM ISTLawsuits over Xarelto began piling up in 2014 and the companies had so far won all six trials over Xarelto's alleged bleeding risk.U.S: Bayer AG and...
Manufacturers of SGLT2 inhibitor Drugs to have to INCLUDE safety WARNING in package: CDSCO Farhat Nasim26 March 2019 1:28 PM ISTNew Delhi: Paying heed to the safety updates of Sodium-Glucose Cotransporter-2 (SGLT2) including medicines such as Canagliflozin, Dapagliflozin,...
Lupin, YL Biologics gets PMDA approval for Etanercept biosimilar in Japan Farhat Nasim26 March 2019 10:00 AM IST"YL Biologics Ltd, a joint venture between Lupin's subsidiary Lupin Atlantis Holdings SA (LAHSA) and Yoshindo Inc in Japan, and Lupin (through its...
Lupin gets USFDA nod to Sildenafil tablets to treat erectile dysfunction Farhat Nasim26 March 2019 9:50 AM ISTSildenafil tablets are a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED). The product is a generic...
Sun Pharma gets one observation from USFDA for Baska plant Farhat Nasim26 March 2019 9:40 AM ISTThe Baska injectibles plant had recently filed for approvals to sell its products in the US, which is currently Sun Pharma's biggest market. The...
Government notifies Drugs and Clinical Trial Rules 2019 Meghna A Singhania26 March 2019 9:31 AM ISTThe new rules will ensure patient safety, as they would be enlisted for trials with informed consent. The ethics committee will monitor the trials and...
OxyContin maker Purdue Pharma agrees to settle Oklahoma opioid case: Source Farhat Nasim26 March 2019 9:25 AM ISTU.S: Purdue Pharma LP has agreed to settle a lawsuit by the state of Oklahoma accusing the OxyContin painkiller maker of helping fuel an opioid abuse...
