Abbreviated New Drug Applications
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Lupin Receives Tentative Nod For Anti-Seizure Drug; Stock Edges Higher
"The company (Lupin) has received tentative approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Brivaracetam Tablets," Lupin said
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Zydus Cadila Gets US Regulator's Nod To Sell Blood Pressure Drug
The group has now more than 150 approvals and has so far filed over 300 abbreviated new drug applications (ANDAs) since the commencement of filing process in FY2003-04, it added.
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Zydus Cadila Gets US Regulator's Nod For Drug, Shares Jump 2%
The company has more than 140 approvals and has so far filed over 300 abbreviated new drug applications (ANDAs) since it commenced filings in 2003-04.
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Sun Pharma Receives US Drug Regulator Nod For Anti-Cholesterol Drug
One of the company's wholly-owned subsidiaries has received final approval from the USFDA for its abbreviated new drug application (ANDA) for generic version of Zetia, ezetimibe tablets.
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Natco Pharma Launches Generic Influenza Treatment Capsules In US
In August this year, Natco Pharma received a final approval for its abbreviated new drug application for generic versions of Tamiflu oral capsules from the US drug regulator.
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Lupin Gets USFDA Nod For Generic Pain Relieving Drug
Currently, Lupin has the fifth largest pipeline of abbreviated new drug application (ANDA) filings pending approval with the USFDA.
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Indian Pharma's Focus On Acquisitions To Limit Deleveraging: Fitch
New Delhi: In line with global trends in thepharmaceuticals sector, the focus of domestic drug firms on acquisitionsto consolidate their position will limit deleveraging for thetime being, rating agency Fitch has said. "The ongoing focus of the top Indian pharma companies' onselective acquisitions to limit deleveraging over the shortterm," Fitch...
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Marksans Pharma Gets US Drug Regulator's Approval For Allergy Drug
In a BSE filing today, Marksans Pharma said, "USFDA has granted approval for an abbreviated new drug application (ANDA) for loratadine liquid filled capsules 10 mg."
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Dr Reddy's Launches Chronic Kidney Disease Generic Drug In US
Drug firm Dr Reddy's Laboratories on Monday said it has launched in the US generic Paricalcitol injection used for treatment associated with chronic kidney disease.
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Natco To File Over 10 New Drug Applications In US In Next Two Fiscals
Drug firm Natco Pharma is aiming to file over 10 Abbreviated New Drug Applications (ANDAs) in the US in the next two financial years to expand its presence in the American market.
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Glenmark Gets USFDA Nod For Skin Lesion Treatment Gel
Glenmark Pharmaceuticals has received final approval from the US health regulator for generic Diclofenac Sodium gel used for treatment of skin lesion.
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Cipla Gets USFDA Nod For Overactive Bladder Treating Drug
Pharma major Cipla on Friday said it has received final approval for its Abbreviated New Drug Application (ANDA) for Darifenacin extended-release tablets from the United States Food and Drug Administration (USFDA).
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Natco Pharma Shares Soar Over 7% On Nod For Tamiflu Drugs
Shares of Natco Pharma on Thursday advanced by over 7 per cent following the company receiving final approval for its Abbreviated New Drug Application (ANDA) for generic versions of Tamiflu oral capsules from the US Food and Drug Administration.
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Dr Reddy's Completes Acquisition Of Products From Teva Pharma
Dr Reddy's Laboratories on Wednesday said it has successfully completed the $350-million (around Rs 2,300 crore) acquisition of eight abbreviated new drug applications (ANDAs) in the US from Teva Pharmaceutical Industries and an affiliate of Allergan plc.
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Sun Pharma Gets US Regulator's Nod For Generic Diabetes Treatment Drug
Sun Pharmaceutical Industries has received a final nod from the US health regulator for its generic Metformin Hydrochloride extended release tablets used for treatment of diabetes, and plans to launch them in next few weeks in the American market.
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Lupin Receives Tentative Nod For Anti-Seizure Drug; Stock Edges Higher
"The company (Lupin) has received tentative approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Brivaracetam Tablets," Lupin said
-
Zydus Cadila Gets US Regulator's Nod To Sell Blood Pressure Drug
The group has now more than 150 approvals and has so far filed over 300 abbreviated new drug applications (ANDAs) since the commencement of filing process in FY2003-04, it added.
-
Zydus Cadila Gets US Regulator's Nod For Drug, Shares Jump 2%
The company has more than 140 approvals and has so far filed over 300 abbreviated new drug applications (ANDAs) since it commenced filings in 2003-04.
-
Sun Pharma Receives US Drug Regulator Nod For Anti-Cholesterol Drug
One of the company's wholly-owned subsidiaries has received final approval from the USFDA for its abbreviated new drug application (ANDA) for generic version of Zetia, ezetimibe tablets.
-
Natco Pharma Launches Generic Influenza Treatment Capsules In US
In August this year, Natco Pharma received a final approval for its abbreviated new drug application for generic versions of Tamiflu oral capsules from the US drug regulator.
-
Lupin Gets USFDA Nod For Generic Pain Relieving Drug
Currently, Lupin has the fifth largest pipeline of abbreviated new drug application (ANDA) filings pending approval with the USFDA.
-
Indian Pharma's Focus On Acquisitions To Limit Deleveraging: Fitch
New Delhi: In line with global trends in thepharmaceuticals sector, the focus of domestic drug firms on acquisitionsto consolidate their position will limit deleveraging for thetime being, rating agency Fitch has said. "The ongoing focus of the top Indian pharma companies' onselective acquisitions to limit deleveraging over the shortterm," Fitch...
-
Marksans Pharma Gets US Drug Regulator's Approval For Allergy Drug
In a BSE filing today, Marksans Pharma said, "USFDA has granted approval for an abbreviated new drug application (ANDA) for loratadine liquid filled capsules 10 mg."
-
Dr Reddy's Launches Chronic Kidney Disease Generic Drug In US
Drug firm Dr Reddy's Laboratories on Monday said it has launched in the US generic Paricalcitol injection used for treatment associated with chronic kidney disease.
-
Natco To File Over 10 New Drug Applications In US In Next Two Fiscals
Drug firm Natco Pharma is aiming to file over 10 Abbreviated New Drug Applications (ANDAs) in the US in the next two financial years to expand its presence in the American market.
-
Glenmark Gets USFDA Nod For Skin Lesion Treatment Gel
Glenmark Pharmaceuticals has received final approval from the US health regulator for generic Diclofenac Sodium gel used for treatment of skin lesion.
-
Cipla Gets USFDA Nod For Overactive Bladder Treating Drug
Pharma major Cipla on Friday said it has received final approval for its Abbreviated New Drug Application (ANDA) for Darifenacin extended-release tablets from the United States Food and Drug Administration (USFDA).
-
Natco Pharma Shares Soar Over 7% On Nod For Tamiflu Drugs
Shares of Natco Pharma on Thursday advanced by over 7 per cent following the company receiving final approval for its Abbreviated New Drug Application (ANDA) for generic versions of Tamiflu oral capsules from the US Food and Drug Administration.
-
Dr Reddy's Completes Acquisition Of Products From Teva Pharma
Dr Reddy's Laboratories on Wednesday said it has successfully completed the $350-million (around Rs 2,300 crore) acquisition of eight abbreviated new drug applications (ANDAs) in the US from Teva Pharmaceutical Industries and an affiliate of Allergan plc.
-
Sun Pharma Gets US Regulator's Nod For Generic Diabetes Treatment Drug
Sun Pharmaceutical Industries has received a final nod from the US health regulator for its generic Metformin Hydrochloride extended release tablets used for treatment of diabetes, and plans to launch them in next few weeks in the American market.
