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Latest Articles in usfda

Zydus Cadila Gets Tentative Nod From USFDA To Market Cancer Drug

The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad

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Caplin Steriles Gets USFDA Nod For Generic Migraine, Cluster Headache Injection

Shares of Caplin Point Laboratories were trading at Rs 690.45 per scrip on BSE, up 0.14 per cent from its previous close.

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Lupin Launches Generic Antifungal Product In US Market

Tavaborole Topical Solution is generic equivalent of Anacor Pharmaceuticals' Kerydin Topical Solution and is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.

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Alembic Pharma Gets USFDA Nod For Cancer Treatment Drug

The tablet in combination with gemcitabine is also indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

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Alembic Pharmaceuticals Gets USFDA Nod For Anti-Depressant Drug

Quoting IQVIA data, Alembic Pharma said Desipramine Hydrochloride Tablets have an estimated market size of USD 7 million for twelve months ending March 2021.

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Lupin Arm Gets Supplemental New Drug Application Approval From USFDA For Solosec

Shares of Lupin Ltd closed at Rs 1,146.25 per scrip on BSE, down 0.26 per cent from its previous close.

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Alembic Pharma Gets USFDA Nod For Generic Nitrofurantoin Capsules

Shares of Alembic Pharmaceuticals were trading at Rs 982.40 apiece on BSE, down 0.12 per cent from its previous close.

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Glenmark Gets USFDA Nod For Generic Lung Cancer Drug

The company's product is the generic version of Boehringer Ingelheim Pharmaceuticals Inc's Ofev capsules.

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Zydus Cadila Gets USFDA Approval For Generic Cancer Drug

The group now has 319 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of the filing process in 2003-04

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Zydus Cadila Gets Tentative USFDA Nod To Market Generic Sclerosis Treatment Drug

The company has received tentative approval from the US Food and Drug Administration (USFDA) to market the product in the strength of .25 mg

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Glenmark Pharma Gets USFDA Nod For Inhalation Product

Glenmark Pharma said the Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vials will be manufactured in the company's North American manufacturing facility based in Monroe, North Carolina, and marks the company's first nebulizer approval.

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Cipla Gets USFDA Nod For Inhalation Product

Brovana is used in maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

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Dr Reddy's Laboratories launches Icosapent Ethyl Capsules in US

Shares of Dr Reddy's were trading 0.14 per cent lower at Rs 5,272.05 apiece on the BSE.

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Alkem Gets Two Observations From USFDA For St Louis-Based Formulation Plant

An FDA Form 483 is issued to a firm management at the conclusion of an inspection when an investigator has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic Act and related Acts.

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Lupin Gets USFDA Nod To Market Sevelamer Hydrochloride Tablets

Sevelamer Hydrochloride Tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.

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