Mylan’s remdesivir will be available to patients in India at July at Rs.4,800 Kumar Jeetendra | July 6, 2020 Drugmaker Mylan NV said on Monday it secured approval to establish its generic model of Gilead Sciences Inc’s Covid-19 therapy medication remdesivir in India this month at $4,800 per 100 mg vial, as illnesses surge on earth’s third worst-hit country by herpes. The Drug Controller General of India (DCGI) accepted Mylan’s remdesivir model, to be …
Strides Pharma gains on USFDA endorsement Kumar Jeetendra | July 9, 2020 Strides Pharma Science climbed 1.28percent to R S 416.60 as a result of its Singapore-based subsidiary, Strides Pharma Global, received US FDA approval for butalbital, acetaminophen, caffeine, and codeine phosphate capsules. According to IQVIA MAT May 2020 statistics, the US market for butalbital, acetaminophen, caffeine, and codeine phosphate capsules, and 50 mg/325 mg/40 mg/30 mg, …
Pfizer, BioNTech’s coronavirus immunizations get FDA’s ‘most optimized plan of attack’ status Kumar Jeetendra | July 13, 2020 The candidates, both BNT162b1 and BNT162b2, would be the most complex of at least four vaccines getting analyzed by most firms in ongoing trials in the United States and Germany. Pfizer’s shares were up roughly 2% and U.S.-listed stocks of BioNTech were up roughly 6 percent before the bell. Earlier this month, the firms said …
Zydus Cadila gets final approval from USFDA to Advertise generic tension headache Pills Kumar Jeetendra | July 19, 2020 Medication firm Zydus Cadila on Saturday said it has received final approval from the US health regulator to market generic Butalbital, Acetaminophen and Caffeine combination pills to cure symptoms of tension headaches. The company has obtained final approval from that the United States Food and Drug Administration (USFDA) to market Butalbital, Acetaminophen and Caffeine tablets …
USFDA clears basic salivation test for quicker identification of COVID-19 Kumar Jeetendra | August 16, 2020 Houston, Aug 16 (PTI) The US health watchdog has authorised the emergency use of some new and expensive saliva established laboratory diagnostic test for COVID-19 which might be a game changer in the identification of the infection because it will enable rapid testing among more people easily. Stephen Hahn, the Food and Drugs Administration Commissioner, …
Alembic Pharma gets USFDA’s’ speculative endorsement for type 2 diabetes DRUG Kumar Jeetendra | August 29, 2020 In a regulatory filing, Alembic Pharmaceuticals said it has received tentative approval by the US Food and Drug Administration (USFDA) for both Empagliflozin and Linagliptin pills in the strengths of 10 mg/5 mg and 25 mg/5 mg. Alembic Pharma stated it is now in litigation with Boehringer at District Court of Delaware and launch of …
Zydus Cadila gets USFDA gesture for muscle relaxant infusion Kumar Jeetendra | September 2, 2020 Zydus Cadila has obtained final acceptance by the US Food and Drug Administration (USFDA) to advertise Cisatracurium Besylate Injection USP at the potency of 20 milligrams (base)/10 mL (two mg/mL) multiple-dose vial, Cadila Healthcare stated in a regulatory filing on Wednesday. The drug will be produced in Liva plant of Cadila Healthcare Ltd.. Zydus Cadila …
Lupin dispatches generic rheumatoid arthritis drug in US market Kumar Jeetendra | September 2, 2020 Medicine manufacturer Lupin on Wednesday said it has established Leflunomide pills, used to treat rheumatoid arthritis, even in the US marketplace. The business has established the product in 10 mg and 20 mg strengths after receiving the approval by the US Food and Drug Administration (USFDA) before, Lupin said in a statement. The item could …
Granules India arm gets USFDA gesture for ADHD treatment drug Kumar Jeetendra | September 11, 2020 New Delhi, Sep 11 (PTI) Medication firm Granules India Friday said its subsidiary has received marketing approval from the US health regulator for Dexmethylphenidate HCl extended-release capsules, used for the treatment of attention-deficit hyperactivity disorder (ADHD). The approved product is bioequivalent to the reference listed drug Focalin XR of Novartis AG. In a BSE filing, …
Zydus Cadila gets USFDA gesture for numerous sclerosis treatment drug Kumar Jeetendra | September 26, 2020 Zydus Cadila has received final approval from the United States Food and Drug Administration (USFDA) to market Dimethyl Fumarate delayed release capsules, (Tecfidera) in the strengths of 120 mg and 240 mg, Zydus Cadila, part of Cadila Healthcare group, said in a regulatory filing. Zydus Cadila said in its approval, the USFDA noted that Zydus …
Lupin gets USFDA gesture to showcase drug for treating backsliding various sclerosis Kumar Jeetendra | October 6, 2020 The company has received approval from the United States Food and Drug Administration (USFDA) to advertise its own Dimethyl Fumarate delayed-release capsules in the strengths of 120 mg and 240 mg, Lupin said in a statement. The item is a generic version of Biogen Inc”s Tecfidera delayed-release capsules at the same strengths, it added. The …
Glenmark Pharma gets USFDA gesture to showcase drug for backsliding numerous sclerosis Kumar Jeetendra | October 7, 2020 Drug major Glenmark Pharma on Wednesday said it has received final approval from the US health regulator for Dimethyl Fumarate delayed-release capsules, used for treatment of relapsing forms of multiple sclerosis in adults. Quoting IQVIA sales data for the 12 month period ending August 2020, Glenmark said Tecfidera delayed-release capsules, 120 mg and 240 mg, …
