Tag Archives: abbreviated new drug application

Zydus Cadila gets US FDA nod to market drug for treatment of epilepsy

AHMEDABAD | MUMBAI | RAJKOT – In a press release submitted to the Indian Bourses on Tuesday, Cadila Healthcare Ltd (Dr Pankaj Patel owned Zydus Cadila group) said of having availed regulatory approval from US Food and Drugs Administration (USFDA) to market drug to treat epilepsy. Zydus Cadila has received the final approval from the

Alembic gets US FDA nod to market diet-exercise equivalent pill, for diabetics

VADODARA (BARODA) | MUMBAI | RAJKOT – In a regulatory filing submitted on Tuesday, Vadodara headquartered and Amin family owned Alembic Pharma said of having got approval from US FDA (Food & Drugs Administration) to market diet and exercise equivalent pill for diabetic patients. Alembic Pharmaceuticals Limited today announced that the company has received tentative

Zydus Cadila gets US FDA nod to market osteoporosis, ortho treatment drug

MUMBAI | AHMEDABAD | RAJKOT – Dr Pankaj Patel led and Ahmedabad headquartered Zydus Cadila Group (Cadila Healthcare Ltd) has received final approval from the US regulators to market ortho treatment medicine, the company said in a press release submitted to the Indian Bourses, today. Zydus Cadila has received the final approval from the USFDA

Zydus Cadila gets US FDA nod to market tablets for diabetic care

AHMEDABAD | MUMBAI | RAJKOT – In a press release submitted to the Indian Bourses on Tuesday, Dr Pankaj Patel led Zydus Cadila group (Cadila Healthcare Ltd.) said of having got approval from US FDA (Food & Drugs Administration) to market Sitagliptin Tablets in dosage value of 25 mg (milligram), 50 mg and 100 mg.

Zydus Cadila gets USFDA nod to market anti-viral drug

AHMEDABAD | MUMBAI | RAJKOT – Dr Pankaj Patel led Zydus Cadila Group got US FDA (Food and Drugs Administration) nod to market anti-viral drug Acyclovir Sodium Injection in composition of 500 mg and 1,000 mg, Cadila Healthcare Ltd said today, in a press release submitted to the Exchanges in India. Zydus Cadila has received

Alembic Pharma gets USFDA nod to market eye-care product, company is fighting litigation over same product in US Court

VADODARA (BARODA) | MUMBAI | RAJKOT – In a regulatory filing submitted to the Exchanges in India, Vadodara Headquartered and Amin family owned 100 years old pharma company – Alembic Pharmaceuticals Ltd said of having got nod from US FDA (Food & Drug Administration) to market eye-drops. Today, the Company today announced that they have

Zydus Cadila gets USFDA nod to market anti-bacterial drug to cure respiratory, skin, ear and sexually transmitted disease

AHMEDABAD | MUMBAI | RAJKOT – Zydus Cadila (Cadila Healthcare Ltd) has received the final approval from the USFDA to market Azithromycin for Oral Suspension USP (US RLD – Zithromax), 100 mg/5 mL and 200 mg/5 mL, the company said in the press release submitted to Exchanges in India on Wednesday. This medication contains Azithromycin, a

Zydus Cadila gets USFDA nod to market impotence treatment drug

AHMEDABAD | MUMBAI | RAJKOT – In a press release submitted to the exchanges in India, Cadila Healthcare Ltd said of having got tentative approval to market drug to cure erectile dysfunction. Zydus Cadila has received the tentative approval from the USFDA to market Vardenafil Hydrochloride Tablets (US RLD-Levitra) in the strengths of 2.5 mg, 5

Zydus Cadila gets USFDA nod to market injection to cure liver injury

AHMEDABAD | MUMBAI | RAJKOT – Cadila Healthcare Ltd in a regulatory filing submitted to the Exchanges in India said of having got US FDA (Food & Drug Administration) nod to market an injection to cure liver injury. Zydus Cadila has received the final approval from the USFDA to market Acetylcysteine Injection (US RLD –

Zydus Cadila cracks one more USFDA approval to cure High Blood Pressure

AHMEDABAD | MUMBAI | RAJKOT – In a regulatory filing submitted to exchanges in India on Friday, Cadila Healthcare Ltd said of getting one more approval from US FDA (Food & Drug Administration) to market tablets to cure high blood pressure and prevent heart failure. Zydus Cadila has received the final approval from the USFDA

USFDA Approvals raining for Zydus Cadila, clicks one more, to market joint-pain (arthritis) treatment drug

AHMEDABAD | MUMBAI | RAJKOT – It seems US FDA (Food & Drug Administration) approvals are raining for Zydus Cadila (Cadila Healthcare Ltd) as the company has been constantly submitting USFDA approval filings on one or the other day in the month of July. Zydus Cadila has one more to its portfolio and this time

Zydus Cadila gets USFDA nod to market four new drugs

AHMEDABAD | MUMBAI | RAJKOT – Zydus Cadila (Cadila Healthcare Ltd) got US FDA (Food & Drugs Administration) nod to market four drugs, this drugs are primely used to treat mental moods/conditions & depression, diet & exercise equivalent to cure diabetic disorders, injection to treat fungal infections and a drug to treat skin allergies, the

Zydus Cadila gets USFDA nod to market anti-migraine drug

AHMEDABAD | MUMBAI | RAJKOT – In a regulatory filing submitted to the Exchanges in India, Cadila Healthcare said of getting US FDA (Food & Drug Administration) approval to market anti-migraine drug Zolmitriptan. Zydus Cadila has received the final approval from the USFDA to market Zolmitriptan Tablets, 2.5 mg and 5 mg. It is used to

Alembic Pharma gets USFDA nod to market drug for Schizophrenia treatment

VADODARA (BARODA) | MUMBAI | RAJKOT – In a regulatory filing submitted to the Indian Stock Exchanges, Alembic Pharmaceuticals Ltd said of having got approval from US FDA (Food & Drug Administration) to market drug to treat schizophrenia in adults. The company has received tentative approval from the USFDA for its Abbreviated New Drug Application (ANDA) for

CSIR-IMTECH and Zydus Cadila shake-hands for development new drugs for drug-resistant infectious diseases

AHMEDABAD | MUMBAI | RAJKOT – The Council of Scientific and Industrial Research (CSIR) – Institute of Microbial Technology (IMTECH), a premier microbial institute under the aegis of the Ministry of Science and Technology, Government of India, recently signed a collaborative research agreement with Zydus Cadila , an innovation-driven global healthcare group, the company (Cadila

Unichem Lab gets USFDA nod for chronic & bronchial (asthama) disorders treatment drug

MUMBAI | RAJKOT – In a regulatory filing submitted today to the exchanges in India Unichem Laboratories Ltd informed of getting final ANDA (Abbreviated New Drug Application) approval from USFDA (US Food & Drug Administration) for Montelukast Chewable Tablet in 4 mg (milligram) and 5 mg dosage. Unichem’s Montelukast Chewable Tablets, 4 mg and 5