Page 19 - Usfda

'USFDA study shows Evusheld retains neutralising activity against Omicron'

The study was done independently by investigators at the US Food and Drug Administration (USFDA), Center for Biologics Evaluation and Research.

US business rebound key to further upsides in Lupin, VAI may offer relief

Clearance for Goa unit is positive; near-term triggers are new launches and market share gains

USFDA inspection of co's US plant completed successfully: Torrent Pharma

Torrent Pharmaceuticals Ltd on Thursday said its manufacturing facility at Levittown, Pennsylvania in the US has successfully completed inspection by the USFDA. The plant was inspected by USFDA (United States Food and Drug Administration) between December 6 and December 15, 2021. At the end of the inspection, no 'Form 483' was issued, the company said in a regulatory filing. As per the USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when an investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. "It is a positive development for the company and is a reflection of our commitment to consistency in quality and compliance with regulatory standards," Torrent Pharmaceuticals said. According to information available on the company's website, the Levittown manufacturing facility is a part of Torrent Pharma's acquisition of Bio-Pharm, Inc (BPI) in 2018. It has ...

Zydus gets orphan drug designation from USFDA for antimalarial compound

The orphan drug designation provides eligibility for certain development incentives

US FDA clears Lupin's Goa plant, paves way for new product approvals

Goa plant has an annual capacity of 6 billion units of tablets, capsules or oral suspension drugs. It accounts for 18-20% of firm's US revenue

Lupin receives inspection report from USFDA for Goa manufacturing facility

Homegrown pharma major Lupin Ltd on Tuesday said it has received the Establishment Inspection Report (EIR) from USFDA for its Goa manufacturing facility after an inspection in Sept 2021

Zydus Cadila gets USFDA approval to market generic schizophrenia drug

Cariprazine is an atypical antipsychotic medication used for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar disorder.

Dr Reddy's launches drug in US to treat high blood pressure, heart failure

The tablet is the generic therapeutic equivalent of Diovan, approved by the US Food and Drug Administration

Alembic gets USFDA nod for generic hypertension treatment drug

Alembic said it has so far received 15 product approvals this year

Biotechnology major Biocon gets USFDA approval for generic product

The product is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant

Alembic Pharma gets USFDA nod for formoterol fumarate inhalation solution

Alembic Pharmaceuticals Ltd on Tuesday said it has received final approval from the US Food & Drug Administration (USFDA) for its generic version of formoterol fumarate inhalation solution used for the treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease. The approval for the abbreviated new drug application (ANDA) for formoterol fumarate inhalation solution is for 20 mcg/2 ml per unit-dose vial. It is therapeutically equivalent to Mylan Specialty's 'Perforomist Inhalation Solution', 20 mcg/2 ml per unit-dose vial, Alembic Pharmaceuticals said in a regulatory filing. The formoterol fumarate inhalation solution indicated for long term, twice daily -- morning and evening -- administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, it added. "This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies Pvt .

Zydus Cadila gets USFDA nod for cancer drug with 180-days exclusivity

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

Leading drug makers Sun Pharma, Lupin recall products in US market

According to USFDA, the Mumbai-based drug maker is recalling the affected lot due to "failed moisture limits."

Biocon's insulin biosimilar Glargine gets preference in top US formulary

The USFDA had approved biosimilar Insulin Glargine-yfgn injection (Semglee) as the first interchangeable biosimilar product in July this year

Gland Pharma gets tentative nod from USFDA for generic Sugammadex injection

Drug firm Gland Pharma on Friday said it has received a tentative nod from the US health regulator for generic Sugammadex injection, which is indicated for reversing the effects of the muscle relaxants rocuronium bromide and vecuronium bromide given to patients during surgery. The company "has received tentative approval from the United States Food and Drug Administration (USFDA) for Sugammadex injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) single-dose vial...", Gland Pharma said in a regulatory filing. The product is the generic version of Merck Sharp & Dohme Corp's Bridion injection, 100 mg/mL, it added. The company will launch the product through its marketing partner on receipt of final approval, Gland Pharma said. According to IQVIA, the Sugammadex injection, 200 mg/2 mL and 500 mg/5 mL single-dose vial had US sales of about USD 615 million for 12 months ended April 2021, it added. Sugammadex injection is used to reverse the effects of the muscle relaxants ...

Zydus Cadila gets tentative nod from USFDA to market generic acne drug

Drug firm Zydus Cadila on Friday said it has received tentative nod from the US health regulator to market generic Adapalene and Benzoyl Peroxide gel used for treatment of acne in the American market. The company has received tentative approval from the United States Food and Drug Administration (USFDA) to market Adapalene and Benzoyl Peroxide Gel 0.3 per cent/2.5 per cent, Zydus Cadila said in a statement. The drug will be manufactured at the group's topical plant at Ahmedabad, it added. Adapalene and Benzoyl Peroxide combination is used to treat acne. It works by killing the bacteria that cause acne and by keeping the skin pores clean, Zydus Cadila said. The group now has 323 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of its filing process, it added. Shares of Cadila Healthcare, the listed entity of the group, were trading at Rs 550.55 per scrip on BSE, up 0.18 per cent from their previous close.

Lupin gets tentative nod from USFDA to market generic Brexpiprazole tablets

The product is a generic version of Otsuka Pharmaceutical Co Ltd's Rexulti tablets in the same strengths

US FDA okays Covid booster shot for people above 65, or at high-risk

The US Food and Drug Administration (FDA) has authorised booster shots of the Pfizer Covid-19 vaccine for people aged 65 and older or at high-risk

Glenmark Pharma gets USFDA nod for generic antibiotic cream

Glenmark Pharma said it has received approval from the US health regulator to market Clindamycin Phosphate Foam, an antibiotic used for treating bacterial infections, in the American market

Lupin's underperformance may continue on US-driven regulatory challenges

US sales trajectory, margins key triggers over the next couple of quarters