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USFDA News

08 Apr 2023

American Court Halts Abortion Pill Mifepristone's USFDA Approval

Mifepristone is one of two drugs used for medication abortion in the United States, along with misoprostol, which is used to treat other medical conditions.

12 Dec 2017

'Flushable' pregnancy test gets FDA's approval; set for 2018 launch

Made with a special paper that works long enough to take the test and but then degrades in water, the pregnancy test has no glass and requires no batteries.

21 Nov 2017

Silver lining for leukemia patients, new possibility for cure found

The development comes after the US Food and Drug Administration last year approved a cell-based gene therapy, namely the CAR T-cell treatment.

Dr Reddy's Lab stocks

21 Sep 2017

Dr Reddy's shares jump 7.5%; mcap rises by Rs 2,864 crore

The company's market valuation went up by Rs 2,864.35 crore to Rs 41,223.35 crore.

Sun Pharmaceutical Industries

03 Sep 2017

Sun Pharma sees single-digit decline in revenues for FY18

On US FDA inspection, Shanghvi said on completion of re- inspection, the USFDA issued nine observations for the Halol facility and the company is currently in the process of implementing the requisite remediation steps.

29 Aug 2017

Sindoor may carry religious significance, but it is unsafe too! - Read

The FDA’s limit for lead in cosmetics is 20 micrograms per gram. Nineteen percent of the US samples and 43 percent of the India samples exceeded that limit.

Dr Reddy's Laboratories

28 Aug 2017

Class action lawsuit filed against Dr Reddy's in US

Drug firm Dr Reddy's Laboratories on Monday said a class action lawsuit has been filed against it in the US by an investor alleging misleading statements in violation of the US federal securities laws.

Cadila Healthcare

24 Aug 2017

Cadila Healthcare soars 7% on USFDA nod for hypertension drug

The scrip settled 7.02 per cent higher at Rs 494.95 on the BSE. In the intra-day trade, the stock climbed 8.95 per cent to the day's high of Rs 503.90 on the BSE.

03 May 2017

Lupin extends losses, loses m-cap by Rs 3,315 crore in 2 days

Registering losses for the second day, Lupin on Wednesday fell by 3 percent on US health regulator's observations for its Goa plant.

Sun Pharmaceutical Industries

22 Apr 2017

USFDA issues 11 observations for Sun Pharma's Dadra facility

Drug major Sun Pharmaceutical Industries has received 11 observations from the US health regulator after inspection of its Dadra facility.

04 Apr 2017

Cipla gets USFDA nod for generic HIV drug

Cipla has received approval from the US health regulator for its generic Abacavir and Lamivudine tablets used for treatment of HIV infection.

28 Feb 2017

Pharma major Lupin gets USFDA nod to market colonoscopy drugs, pain relief

The approved product is indicated for relief of moderate to moderately severe pain. Percocet tablets had US sales of USD 838.7 million.

07 Jul 2016

USFDA clears Lupin's Goa facility; stocks up 6.25%

Pharma firm Lupin has received Establishment Inspection Report (EIR) from the US health regulator for its Goa facility regarding a inspection done by the USFDA in July last year.

25 May 2016

Zydus Cadila gets USFDA's final nod for fungal treatment drug

The Zydus Cadila has received final approval from the US Food and Drug Administration (USFDA) to market Voriconazole tablets in strengths of 50 and 200 mg, Cadila Healhtcare said in a BSE filing.

25 Apr 2016

Are e-cigarettes beneficial or cause harm? This is what experts say!

The team also warned that heavy regulation and taxation of e-cigarettes will counteract the benefit that these products can provide.

Sun Pharmaceutical Industries

11 Apr 2016

Sun Pharma gets USFDA nod for eye inflammation drug

The company is likely to commercialise BromSite through its newly formed US-based division Sun Ophthalmics in the second half of 2016.

Ipca Laboratories

08 Apr 2016

Ipca shares down 14% at 52-week low on fallout of USFDA warning

The shares of Ipca Laboratories slumped over 14 percent as Switzerland-based Global Fund, which financially supports various disease eradication programmes, decided it will not source its malaria drug, the company notified the BSE.

Dr Reddy's Laboratories

06 Apr 2016

USFDA actions hurting exports, need govt intervention: Dr Reddy's

Asserting that regulatory action by the US Food and Drug Administration (USFDA) on leading Indian firms has impacted exports from the country, Dr Reddy's Laboratories Chairman Satish Reddy Wednesday asked for a dialogue between government and US health regulator.

31 Mar 2016

Lupin launches generic Aricept tablets in US market

Drug major Lupin has launched Donepezil Hydrochloride tablets, used in treating Alzheimer's disease, in the US market after having received the US health regulator USFDA's nod for the product earlier

29 Mar 2016

Natco Pharma shares extend fall; down 5% on USFDA observations

Continuing to fall for the second consecutive day, shares of Natco Pharma fell by nearly 5 percent today, after the company received 483 observations from the USFDA after inspection of its two facilities.

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