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Zydus gets USFDA nod for clinical trial anti-diabetes molecule

Last Updated: Wednesday, October 23, 2013, 15:10

Drug firm Cadila Healthcare today said the Zydus group has received approval from the US health regulator for initiating Phase I clinical trial for ZYDPLA1 - a new molecule aimed for diabetes treatment.

Glenmark gets USFDA nod for skin infections cream

Last Updated: Monday, September 30, 2013, 15:36

Glenmark Pharmaceuticals on Monday said it has received approval from the US health regulator for its generic Hydrocortisone Butyrate Cream used for treating variety of skin infections.

USFDA issues warning letter to Mumbai-based Aarti Drugs

Last Updated: Wednesday, September 25, 2013, 23:01

US health regulator has issued a warning letter to Mumbai-based Aarti Drugs, saying it is not satisfied with the company's response to its inspections at the company's Maharashtra facilities and noted that they lack sufficient corrective actions.

Lupin gets USFDA nod for insomnia drug

Last Updated: Monday, September 16, 2013, 18:12

"Lupin's wholly-owned US subsidiary Lupin Pharmaceuticals Inc shall commence marketing the product shortly," it added.

FDA warns 2 Indian firms for manufacturing lapses

Last Updated: Sunday, August 25, 2013, 18:40

In its latest action against Indian drug makers, the US health regulator FDA has red- flagged "significant deviations" from good manufacturing practices at two Indian pharmaceutical companies.

Wockhardt shares fall for 2nd day; slump 19%

Last Updated: Friday, May 24, 2013, 12:04

Similarly at the NSE, the stock nosedived by 19.31 percent to Rs 1,060.

Generic drug product application to cost Rs 30 lakh in US

Last Updated: Wednesday, December 19, 2012, 16:40

Indian generic drug exporters to US will have to pay about Rs 30 lakh (about USD 54,700) each as fee for every new product application they file with the US health regulator as per an amended law in that country, Parliament was informed on Wednesday.

Zydus Cadila gets USFDA nod for schizophrenia drug

Last Updated: Tuesday, July 31, 2012, 21:52

Drug firm Zydus Cadila Tuesday said it has received the US health regulator's approval to market aripiprazole orally disintegrating tablets, used in treating schizophrenia, in the American market.

Glenmark gets final USFDA nod for oral contraceptive pills

Last Updated: Tuesday, April 03, 2012, 14:03

Glenmark Pharmaceuticals on Tuesday said it has received final approval by the US health regulator to market its oral contraceptive Desogestrel and Ethinyl Estradiol tablets in the American market.

USFDA to import cancer drug Lipodox from Sun Pharma

Last Updated: Thursday, February 23, 2012, 21:15

US health regulator has said it will import cancer drug Lipodox from India's Sun Pharma to meet the shortage of another similar medicine Doxil.

Sun Pharma gets USFDA nod for generic cardiac capsules

Last Updated: Monday, October 31, 2011, 19:07

Drug maker Sun Pharmaceutical on Monday said it has received approval from the US health regulator to market generic Diltiazem HCl extended-release capsules used for treating hypertension and angina in the American market.

Lupin can market generic anti-epilepsy drug in US

Last Updated: Wednesday, October 19, 2011, 18:25

Drug maker Lupin Tuesday said it has received final approval from the US health regulator to market a generic version of UCB's Keppra Oral Solution, an anti-epilepsy drug, in the American market.