USFDA supports remdesivir, first medication to treat Covid-19 patients Kumar Jeetendra | October 23, 2020 Washington: The United States Food and Drug Administration (FDA) has approved Remdesivir for the treatment of coronavirus, Al Jazeera reported citing a statement issued by Gilead Sciences, Inc.. Based on the press release by the company, previously authorised by the FDA for just emergency use to deal with Covid-19 patients, Veklury or Remdesivir is now …
Glenmark Pharma gets USFDA gesture for Tacrolimus capsules Kumar Jeetendra | November 11, 2020 Tacrolimus capsule is an immunosuppressant and can be employed for preventing organ rejection in certain patients after kidney, liver, or heart transplant. Glenmark Pharmaceuticals Inc, USA, has been granted final approval by the United States Food and Drug Administration (USFDA) for Tacrolimus Capsules USP in the strengths of 0.5 mg, 1 mg and 5 mg, …
Lupin, Concord Biotech get USFDA gesture for generic immunosuppressant cases Kumar Jeetendra | November 12, 2020 New Delhi, Nov 12 (PTI) Drug firm Lupin on Thursday stated that in alliance with Concord Biotech, it has obtained acceptance from the US health regulator to market generic immunosuppressant Tacrolimus capsules used in the Western industry. In cooperation with Concord Biotech, the business has obtained approval from the United States Food and Drug Administration …
USFDA Approved Foundation Medicine’s FoundationOne®Liquid CDx, a Pan-Tumor Liquid Biopsy Genomic Test for Late Stage Cancer Patients now Available in India Kumar Jeetendra | November 19, 2020 Mumbai, 18 November 2020: Roche Products (India) Pvt. Ltd. (Roche Pharma India) announces the launch of FoundationOne®Liquid CDx, Foundation Medicine’s comprehensive pan-tumor liquid biopsy test for patients with solid tumors in India. US FDA approved the FoundationOne®Liquid CDx, a comprehensive genomic profiling (CGP) test on August 26. This is the first test that can analyze …
Alembic Pharma gets USFDA endorsement for Metolazone tablets Kumar Jeetendra | December 3, 2020 New Delhi, Dec 3 (PTI) Drug firm Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator for Metolazone tablets, indicated for the treatment of salt and water retention caused by heart failure or kidney disease. The approved product is therapeutically equivalent to the reference listed drug product Zaroxolyn Tablets 2.5 …
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 …
... 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 …
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 …
Granules India gets USFDA endorsement for Metformin Hydrochloride ER tablets Kumar Jeetendra | January 13, 2021 Granules India Limited today announced that United States Food & Drug Administration (USFDA) has given the final approval for its abbreviated new drug application (ANDA) for Metformin Hydrochloride extended-release tablets USP, 500 mg and 1,000 mg. These tablets are the generic equivalent of Glumetza ER tablets, 500 mg & 1,000 milligrams of Bausch Health US …
India needs Pfizer to do nearby examination for approval: Official Kumar Jeetendra | January 13, 2021 Any vaccine manufacturer, such as Pfizer Inc, which has sought emergency-use authorisation for its COVID-19 shot in India, must run a neighborhood”bridging” safety and immunogenicity study to be considered for the country’s immunisation programme, a senior government official told Reuters. Serum Institute of India, the local maker of the vaccine developed by AstraZeneca Plc and …
Strides Pharma Science arm gets USFDA gesture for HIV treatment drug Kumar Jeetendra | January 15, 2021 Drug firm Strides Pharma Science on Friday said its step-down wholly-owned subsidiary, Strides Pharma Global, has obtained approval from the US health regulator for Emtricitabine and Tenofovir Disoproxil Fumarate pills, used to treat HIV. The approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Truvada tablets of Gilead Sciences. Strides Pharma …
Strides Pharma gets USFDA gesture for conventional medication Kumar Jeetendra | January 25, 2021 New Delhi, Jan 25 (PTI) Strides Pharma Science on Monday said it has received approval from the US health regulator to market generic Ursodiol capsules, used in the treatment of Primary Biliary Cirrhosis (PBC), in the American market. The company”s product is bioequivalent and therapeutically equivalent to Allergan Sales” Actigall capsules, it added. Based on …
