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USFDA approval

Indoco Remedies gets USFDA nod to market Lofexidine tablets with 180 days exclusivity

Indoco Remedies gets USFDA nod to market Lofexidine tablets with 180 days exclusivity

Wed, Aug 21, 2024

Indoco Remedies Ltd has received final approval from the USFDA to market its generic Lofexidine tablets, used in opioid discontinuation treatment. The approval grants Indoco 180 days of Competitive Generic Therapy (CGT) exclusivity.

Granules India gets USFDA nod for generic Glycopyrrolate oral solution

Granules India gets USFDA nod for generic Glycopyrrolate oral solution

Tue, Aug 20, 2024

Granules India announced that its subsidiary, Granules Pharmaceuticals Inc, has received approval from the US FDA for a generic version of Glycopyrrolate Oral Solution, 1 mg/5 mL. This anticholinergic medication is indicated for pediatric patients aged 3 to 16 years with neurological conditions associated with drooling.

Glenmark Pharma share price pharmaceuticals firm gets usda nod for seizure treatment drug Topiramate capsules

Glenmark Pharma share price pharmaceuticals firm gets usda nod for seizure treatment drug Topiramate capsules

Wed, Jul 17, 2024

Glenmark's Topiramate capsules USP, 15 mg and 25 mg have been determined by the FDA to be bioequivalent and therapeutically equivalent to Topamax capsules, 15 mg and 25 mg of Janssen Pharmaceuticals, Inc., and will be distributed in the US by Glenmark Pharmaceuticals Inc., USA, it added.

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Aurobindo Pharma gets USFDA approval for HIV drug

Aurobindo Pharma gets USFDA approval for HIV drug

Wed, Nov 29, 2023

The pharma company has received final approval from the USFDA, US Food and Drug Administration to manufacture and market 600 and 800 mg Darunavir tablets, said the Hyderabad-based drug maker.

Zydus gets USFDA nod for generic acne treatment drug

Zydus gets USFDA nod for generic acne treatment drug

Thu, Aug 31, 2023

The drug firm has received final approval from the US Food and Drug Administration (USFDA) for Isotretinoin Capsules USP (10 mg, 20 mg 30 mg and 40 mg), it said in a statement.

Ajanta Pharma gets USFDA approval for Topiramate Extended-Release Capsules; declines after climbing over 4%

Ajanta Pharma gets USFDA approval for Topiramate Extended-Release Capsules; declines after climbing over 4%

Thu, Aug 31, 2023

Ajanta Pharma stock climbed on the back of the pharmaceutical company receiving final approval from the United States Food and Drug Administration (USFDA) to market Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg, and 200mg.

Gland Pharma surges after FDA completes inspection at drug maker's sterile oncology facility

Gland Pharma surges after FDA completes inspection at drug maker's sterile oncology facility

Mon, Jul 31, 2023

Gland Pharma is scheduled to report its financial results for the April-June period on August 7.

Zydus Lifesciences gets USFDA nod for generic acne-treating drug

Zydus Lifesciences gets USFDA nod for generic acne-treating drug

Mon, Jun 19, 2023

The approval granted by the US Food and Drug Administration (USFDA) is for Minocycline Hydrochloride extended-release tablets of strengths 55 mg, 65 mg, and 115 mg, Zydus Lifesciences said in a regulatory filing.

Natco Pharma gets USFDA approval for Tipiracil Hydrochloride and Trifluridine Tablets

Natco Pharma gets USFDA approval for Tipiracil Hydrochloride and Trifluridine Tablets

Fri, Jun 16, 2023

The US Food and Drug Administration (USFDA) granted final approval to the abbreviated new drug application (ANDA) for Tipiracil Hydrochloride and Trifluridine Tablets, the generic version of Lonsurf sold in the US by Taiho Oncology Inc, Natco said in a regulatory filing.

Zydus gets USFDA nod for generic drug to treat stomach & esophagus problems

Zydus gets USFDA nod for generic drug to treat stomach & esophagus problems

Thu, Jun 08, 2023

Zydus Lifesciences on Thursday said it has received approval from the US health regulator to market a generic drug used to treat certain stomach and esophagus problems.

Healthium Medtech receives US FDA registration for Sri City manufacturing unit in Andhra Pradesh

Healthium Medtech receives US FDA registration for Sri City manufacturing unit in Andhra Pradesh

Wed, Dec 08, 2021

Healthium Medtech on Wednesday said it has received registration approval for its Andhra Pradesh-based manufacturing facility from the US health regulator.

Glenmark Pharma gets USFDA nod for cholesterol lowering drug

Glenmark Pharma gets USFDA nod for cholesterol lowering drug

Fri, Jun 28, 2019

Glenmark Pharmaceuticals Friday said it has received final approval from the US health regulator for Ezetimibe and Simvastatin tablets, used for treating high levels of cholesterol in the blood.

USFDA approval to Zetia tablet gives surge to Cadilla, Sun Pharma shares

Tue, Jun 13, 2017

Hike in the stocks of Cadilla and Sun Pharma can be seen due to approval of Zetia tablet by USFDA. US congress vote in favor of the making the legislative proposal of visa process a law and other important news and discussions are featured in the segment.

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