Nov 23, 2021 01:52 PM IST
The approval for the abbreviated new drug application (ANDA) for formoterol fumarate inhalation solution is for 20 mcg/2 ml per unit-dose vial.
- Nov 20, 2021 03:07 PM IST
The company has received final approval from the US Food and Drug Administration (USFDA) to Decitabine for Injection in the strength of 50 mg/vial single-dose vial, Zydus Cadila said in a statement.
- Nov 18, 2021 02:48 PM IST
The company has received approval from the US Food and Drug Administration (USFDA) for the Nelarabine injection 250 MG/50ML, a generic version of Arranon injection.
- Oct 27, 2021 08:01 AM IST
An authorization for that age group would be would be an important regulatory step toward reaching about 28 million children for inoculation, most of them back in school for in-person learning.
- Oct 26, 2021 06:30 PM IST
The advisers are expected to pay close attention to the rate of rare cases of heart inflammation called myocarditis that have been linked to both the Pfizer/BioNTech and Moderna vaccine, particularly in young men.
- Oct 21, 2021 11:56 AM IST
The Pfizer, Moderna, and Johnson & Johnson vaccines are authorized in the United States. A single dose of any of them may now be used following completion of primary vaccination with a different Covid vaccine.
- Oct 19, 2021 03:53 PM IST
The FDA in September authorized a booster dose of Pfizer Inc and partner BioNTech's two-shot COVID-19 vaccine for those aged 65 and older and some high-risk Americans.
- Oct 11, 2021 03:49 PM IST
Merck and its partner Ridgeback Biotherapeutic said they specifically asked the agency to grant emergency use for adults with mild-to-moderate COVID-19 who are at risk for severe disease or hospitalization. That is roughly the way COVID-19 infusion drugs are used.
- Sep 24, 2021 02:20 PM IST
In a regulatory filing, Caplin Point Laboratories said Amaris Clinicals located at Chennai, has completed a virtual audit from United States Food and Drug Administration (USFDA) with ''nil'' observations.
- Sep 24, 2021 02:12 PM IST
The company's US-based subsidiary Zydus Pharmaceuticals (USA) Inc has received final approval from the US Food and Drug Administration (USFDA) to market Apremilast tablets in the strengths of 10 mg, 20 mg, 30 mg in the US market, Zydus Cadila said in a statement.
- Sep 21, 2021 12:27 PM IST
The Mumbai-based firm has received final approval from the US Food and Drug Administration (USFDA) to market Clindamycin Phosphate Foam (1 per cent) which is a generic version of Mylan Pharmaceuticals Inc's Evoclin Foam.
- Sep 09, 2021 02:12 PM IST
The company has received tentative approval from the US Food and Drug Administration (USFDA) to market Brexpiprazole tablets in the strength of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, the drug firm said in a statement.
- Sep 06, 2021 12:48 PM IST
The company said its subsidiary has received tentative approval from the United States Food and Drug Administration (FDA) for its new drug application for Sitagliptin base 25, 50 and 100 mg tablets.
- Aug 27, 2021 01:39 PM IST
The company’s subsidiary "Eugia Pharma Specialities Ltd has received a 505(b)(2) NDA approval from the US Food & Drug Administration (USFDA) for its Cyclophosphamide Injection 500 mg/2.5 mL and 1 g/5 mL vial,” Aurobindo Pharma said in a regulatory filing.
- Aug 24, 2021 08:02 PM IST
The top infectious disease expert in the US says the Food and Drug Administration’s decision Monday should encourage people who cited lack of approval as a reason for not getting vaccinated.
- Aug 17, 2021 07:58 AM IST
They said the third dose showed significantly higher neutralizing antibodies against the initial SARS-CoV-2 virus compared to the two doses as well as against the Beta and the highly infectious Delta variants.
- Aug 09, 2021 11:25 AM IST
IPCA, which was mainly known a few years ago for anti-malarial medications, is now having a significant contribution from non-anti-malarial medicines
- Aug 05, 2021 02:14 PM IST
The company has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Clomipramine Hydrochloride Capsules USP in the strengths 25 mg, 50 mg, and 75 mg, Alembic Pharmaceuticals said in a regulatory filing.
- Jul 22, 2021 11:04 PM IST
Guillain-Barre syndrome occurs when the body’s immune system mistakenly attacks some of its nerve cells, causing muscle weakness and sometimes paralysis that typically is temporary.
- Jul 21, 2021 05:45 PM IST
Experts say Medicare could seek to lower the therapy's cost to taxpayers by limiting access to the treatment, linking coverage to real-world evidence of patient outcomes, or setting a fixed payment that combines drug reimbursement with other costs related to the treatment.
- Jul 09, 2021 12:23 PM IST
The approved product is therapeutically equivalent to the reference listed drug product Tarceva tablets of OSI Pharmaceuticals, LLC.
- Jul 02, 2021 02:49 PM IST
The company has received final approval from the United States Food and Drug Administration (USFDA) to market Emtricitabine and Tenofovir Disoproxil Fumarate tablets, 100 mg/150 mg, 133 mg/200 mg and 167 mg/250 mg, Zydus Cadila said in a statement.
- Jul 01, 2021 02:07 PM IST
The company has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Nitrofurantoin capsules, USP in the strengths of 25 mg, 50 mg and 100 mg, Alembic Pharma said in a regulatory filing.
- Jun 30, 2021 10:14 AM IST
"Repeated violations at multiple sites demonstrate your company’s corporate oversight and control over the manufacture of drugs is inadequate," the USFDA said in the letter addressed to Vinita Gupta, CEO of Lupin
- Jun 26, 2021 11:26 AM IST
For each vaccine, the fact sheets for healthcare providers have been revised to include a warning that reports of adverse events suggest increased risks of myocarditis and pericarditis, particularly after the second dose and with onset of symptoms within a few days after vaccination, the FDA said.