Dr Reddy’s’ dispatches generic medication in the US market Kumar Jeetendra | January 11, 2021 New Delhi, Jan 11 (PTI) Dr Reddy”s Laboratories on Monday said it has launched Febuxostat tablets, used to treat gout due to high uric acid levels, in the US market. The company has launched the product, which is a generic version of Teijin Ltd”s Uloric tablets, after getting approval from the US Food and Drug …
Cipla recalls over 5.8 lakh packets of gastric ulcer treatment drug in US Kumar Jeetendra | January 10, 2021 New Delhi, Jan 10 (PTI) Drug major Cipla is recalling more than 5.8 lakh packets of a drug for the reduction in the occurrence of gastric ulcers from the US market, as per a report from the US Food and Drug Administration. The medication major is recalling esomeprazole magnesium for delayed-release oral suspension in unit …
Lupin gets USFDA gesture to market generic of sulfamethoxazole, trimethoprim Kumar Jeetendra | January 10, 2021 New Delhi, Jan 6 (PTI) Homegrown pharma major Lupin Ltd on Wednesday said it has received approval from the US health regulator to market its generic version of sulfamethoxazole and trimethoprim oral suspension used in the treatment of bacterial infections. Sulfamethoxazole and trimethoprim oral suspension, 200 mg/40 mg per 5 mL, is indicated for the …
Biotech Team Develops ELISA Protocol for COVID-19 IgG Antibody Detection Kumar Jeetendra | January 7, 2021 Budapest, HU – 6 January 2021 – ZTA Biotech, a Budapest-based biotech startup has announced the breakthrough development of a COVID-19 antibody (IgG) test using the ELISA protocol. This new detection method represents a great step forward in determining if patients have had COVID-19 and if they might still have immunity to the disease. Early …
FDA confirms resubmission new drug application of Alkermes Kumar Jeetendra | January 3, 2021 Alkermes plc announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the company’s New Drug Application (NDA) resubmission for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder, and has assigned the application a new Prescription Drug User Fee Act (PDUFA) target action date …
... Kumar Jeetendra | January 2, 2021 New Delhi: Drug important Glenmark Pharma on Thursday said it has received final approval from the US health regulator for Tadalafil tablets, used to treat erectile dysfunction and enlarged prostate. The business also received two tentative approvals in the US health regulator. Glenmark Pharmaceuticals Ltd has received final approval from the United States Food and …
Zydus Cadila gets DCGI gesture for NAFLD drug in India Kumar Jeetendra | December 30, 2020 New Delhi, Dec 30 (PTI) Drug firm Zydus Cadila on Wednesday said it has received approval from the Drug Controller General of India (DCGI) for Saroglitazar Mg, used for the treatment of non-alcoholic fatty liver disease (NAFLD), in the nation. Zydus Cadila explained the prevalence of NAFLD in India is estimated to be nearly 25-30 …
Lupin receives tentative nod from USFDA for its toenail fungus remedy topical solution Kumar Jeetendra | December 25, 2020 NEW DELHI: Drug company Lupin on Thursday said it has received tentative nod in the US health regulator to market generic Efinaconazole topical solution used for treatment of fungal infections of toenails. The business has received tentative approval to market its Efinaconazole topical solution, 10%, by the United States Food and Drug Administration (USFDA), Lupin …
AstraZeneca says its vaccine need to be powerful in opposition to new coronavirus variant Kumar Jeetendra | December 23, 2020 British drugmaker AstraZeneca Plc told Reuters on Tuesday that its COVID-19 vaccine should be effective against the new coronavirus version, including that studies were under way to completely probe the effect of the mutation. “AZD1222 (AstraZeneca’s vaccine candidate) contains the genetic material of this SARS-CoV-2 virus spike protein, as well as the changes to the …
Glenmark Pharma gets provisional gesture from USFDA for blood thinning drug Kumar Jeetendra | December 21, 2020 Pradaxa is used to prevent blood clots from forming due to certain irregular heart rhythm. Glenmark Pharmaceuticals was granted tentative approval by the United States Food and Drug Administration (USFDA) for Dabigatran Etexilate capsules at the advantages of 75 mg, 110 mg, and 150 mg, the company said in a regulatory filing. Quoting IQVIA sales …
Moderna COVID-19 shots leave distribution centers, broadening US vaccination push Kumar Jeetendra | December 20, 2020 Shipments of Moderna Inc’s COVID-19 vaccine started leaving warehouses early on Sunday, heading for healthcare facilities around the USA in a push to disperse the second authorized coronavirus vaccine. The distribution of Moderna’s vaccine to over 3,700 locations in the United States will vastly expand the rollout started a week by Pfizer Inc.. The U.S. …
Strides Pharma gets USFDA gesture for conventional Oxybutynin Chloride tablets Kumar Jeetendra | December 18, 2020 Drug firm Strides Pharma Science on Friday said its Singapore-based arm has received approval from the US health regulator for generic Oxybutynin Chloride tablets used to treat symptoms of overactive bladder and urinary incontinence. Company’s step-down wholly owned subsidiary Strides Pharma Global Pte Ltd, Singapore, has received approval for Oxybutynin Chloride Tablets USP, 5 mg …
