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Feb 24, 2021 12:13 PM IST The approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Children's Motrin Oral Suspension, 100 mg/mL, of Johnson & Johnson Consumer Inc.
Feb 22, 2021 05:05 PM IST 'It will more likely be smaller immunogencity studies,' said Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER) at USFDA, speaking at BioAsia 2021 virtual event.
Feb 19, 2021 12:32 PM IST The approved product is a generic version of Lundbeck NA Ltd's Northera capsules.
Feb 19, 2021 11:20 AM IST Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Feb 12, 2021 11:27 AM IST The approved product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Deltasone tablets, 10 mg and 20 mg, of Pharmacia and Upjohn Co.
Feb 08, 2021 12:03 PM IST "The United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals'' New Injectable Facility (F-3) located at Karkhadi from January 29-February 5, 2021.
Feb 03, 2021 12:32 PM IST The approved product is a generic version of Qudexy XR Capsules of Upsher-Smith Laboratories, LLC.
Feb 01, 2021 11:09 AM IST The approved product is bioequivalent to the reference listed drug Potassium Chloride Oral Solution of Genus Lifesciences, Inc.
Jan 28, 2021 11:25 AM IST Zydus Cadila, which is a part of Cadila Group, said orphan drug designation provides eligibility for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon USFDA approval.
Jan 27, 2021 04:45 PM IST The company has received abbreviated new drug application (ANDA) approval to market its Zonisamide capsules, USP 25 mg, 50 mg and 100 mg from the United States Food and Drug Administration (USFDA), Unichem Laboratories said in a BSE filing.
Jan 25, 2021 01:58 PM IST The company's product is bioequivalent and therapeutically equivalent to Allergan Sales' Actigall capsules, Strides Pharma Science added.
Jan 25, 2021 01:54 PM IST The product is a generic version of Genzyme Corporation's Renvela tablets in the same strength, Lupin added.
Jan 22, 2021 11:47 AM IST The approved product is therapeutically equivalent to the reference listed drug product ProAmatine tablets of Takeda Pharmaceuticals USA, Inc.
Jan 13, 2021 01:41 PM IST The company has received abbreviated new drug application (ANDA) approval for its Celecoxib capsules in the strengths of 50 mg, 100 mg, 200 mg, and 400 mg from the United States Food and Drug Administration (USFDA), Unichem said in a filing to BSE.
Jan 07, 2021 05:26 PM IST The product will be manufactured at Lupin’s Nagpur-based manufacturing facility.
Dec 21, 2020 11:11 AM IST The approved product is a generic version of Boehringer Ingelheim Pharmaceuticals’ Pradaxa capsules. Pradaxa is used to prevent blood clots from forming because of certain irregular heart rhythm.
Dec 15, 2020 07:02 PM IST The FDA was upbeat on the vaccine, saying there were "no specific safety concerns identified that would preclude issuance of an EUA (emergency use authorization" and confirmed an overall efficacy of 94.1 percent.
Dec 09, 2020 03:32 PM IST Fast Track is a process of the USFDA to expedite the review of drugs to treat serious conditions and fill an unmet medical need. A drug that receives Fast Track Designation is eligible for accelerated approval and priority review, if the relevant criteria are met, Zydus Cadila said in a statement.
Dec 01, 2020 11:41 AM IST The tentatively approved product is the generic version of Inlyta tablets of PF Prism CV.
Nov 24, 2020 02:40 PM IST Watch the video to find out how a dosing error turned into a lucky punch for AstraZeneca and Oxford.
Nov 20, 2020 06:06 PM IST The application to the US Food and Drug Administration (FDA) comes just days after Pfizer and German partner BioNTech reported final trial results that showed the vaccine was 95% effective in preventing COVID-19 with no major safety concerns.
Nov 09, 2020 11:34 AM IST The approved product is therapeutically equivalent to the reference listed drug product lbrance Capsules of Pfizer Inc.
Nov 09, 2020 11:13 AM IST Lupin said it does not believe that this will have an impact on disruption of supplies or the existing revenues from operations of this facility.
Oct 26, 2020 02:21 PM IST The product is generic version of Bausch Health US’ Timoptic-XE ophthalmic gel forming solution in the same strengths, the company added.
Oct 23, 2020 12:47 PM IST The company has received final approval from the US Food and Drug Administration (USFDA)to market its product, which is a generic version of Proventil tablets, Zydus Cadila said in a statement.
