Tag: USFDA
USFDA issues Form 483 with 3 observations to Bliss GVS Pharma,...
Bliss GVS Pharma said the United States Food and Drug Administration (USFDA) has issued form 483 with three minor observations at company’s...
Medical Device alert: USFDA classifies recall of heart devices as most...
New York: The US Food and Drug Administration (USFDA) on Friday classified the recall of Getinge AB's heart devices as the most serious type, saying their use...
Drug recall: Brimonidine Tartrate Ophthalmic Solution recalled due to this reason
Apotex Corp., with the knowledge of the USFDA, is initiating a voluntary recall at the Consumer level for six (6) lots of Brimonidine Tartrate Ophthalmic...
USFDA gives nod for Human Trial of drug for the treatment...
Mumbai: Glenmark Specialty SA, the subsidiary of Glenmark Pharmaceuticals Ltd has received acceptance from the US Food and Drug Administration (USFDA) on its Investigational New...
USFDA flags shortage of medication used to treat breathing conditions
New Delhi: The U.S. health regulator said that it is working to address a shortage of a particular form of albuterol, a medication...
USFDA gives approval for Vigabatrin for Oral Solution
Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Vigabatrin for Oral Solution USP, 500...
USFDA issues Form 483 with 4 observations to Indoco Remedies, Goa
After a GMP inspection of the company's Plant II (Sterile Facility) and Plant III (OSD Facility) in Goa, the United States Food...
USFDA gives nod for Docetaxel Injection USP
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Docetaxel...
USFDA approves bleeding disorder therapy
New Delhi: Sanofi's Altuviiio has gained approval from the U.S. Food and Drug Administration (USFDA) for the treatment of hemophilia A, a...
USFDA issues EIR to Strides for Bangalore facility
The US Food and Drug Administration (USFDA) issued an Establishment Inspection Report (EIR) in connection with the inspection of the business's flagship...
USFDA gives tentative nod for Gabapentin Tablets, 300 mg and 600...
Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Gabapentin Tablets (Once-Daily), 300 mg and...
USFDA gives approval for Saxagliptin Tablets 2.5 mg and 5 mg
Glenmark Pharmaceuticals has received a second tentative approval by the United States Food & Drug Administration (USFDA) for Saxagliptin Tablets, 2.5 mg...
USFDA issues Form 483 with 8 observations to Cipla for Pithampur...
Cipla Ltd. announced that the US Food and Drug Administration (USFDA) issued eight (8) observations following a current good manufacturing practices (cGMP)...
Drug recall: 3,665 Bottles of this antifungal drug recalled due to...
New Delhi: Biocon is recalling 3,665 bottles of antifungal medication in the US market for “failed degradation specifications,” according to the US Food...
Medical Device alert: USFDA classifies recall of these devices as most...
Bengaluru: The U.S. Food and Drug Administration (USFDA) classified the recall of Dutch medical device maker Philips' respiratory machines as most serious, saying their use...
USFDA gives tentative nod for these two generic drugs
New Delhi: Zydus Lifesciences announced that it has received provisional approval from the US health regulator to market two generic medications used...
USFDA gives VAI classification to Aurobindo Pharma for Telangana plant
Aurobindo Pharma said it has received Voluntary Action Indicated (VAI) from the US health regulator for its Telangana-based manufacturing plant.
CDSCO panel gives nod for Icosapent Ethyl Capsules
Icosapent Ethyl Capsules 500mg and 1000mg, which are indicated as an adjunct therapy for severe hypertriglyceridemia, have been manufactured and marketed by...
USFDA gives nod for Aflibercept injection to treat infants with prematurity...
Tarrytown: Regeneron Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (USFDA) has approved EYLEA (aflibercept) injection to treat preterm infants with retinopathy of...
USFDA issues Form 483 with 2 observations to Laurus Labs for...
Telangana: Laurus Labs has announced that the company has received Form 483 with two observations from the US Food and Drug Administration...
Drug recall: Over 34,000 bottles of Diltiazem HCL capsules recalled due...
New Delhi: Drug major Sun Pharma is recalling over 34,000 bottles of a generic medication, used to treat high blood pressure, in the...
USFDA gives nod for generic Lenalidomide capsules
Sun Pharmaceutical Industries announced that one of its wholly owned subsidiaries has received final approval from the USFDA for its Abbreviated New...
USFDA gives approval for Glycopyrrolate Injection USP
Lupin has received approval from the United States Food and Drug Administration (USFDA) for its abbreviated New Drug Application for Glycopyrrolate Injection...
USFDA gives approval for Diclofenac Sodium Topical Solution USP
Aurobindo Pharma announced that its step-down subsidiary company, Aurolife Pharma LLC., has received a final approval from the US Food & Drug...
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Govt Job: For Pharmacist at Reserve Bank of India
The Reserve Bank of India was established on April 1, 1935 in accordance with the provisions of the Reserve Bank of India...
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