Page 7 - Usfda

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

Lupin's Goa plant gets 7 observations from USFDA, firm unperturbed

Says confident of resolving matter, does not share nature of observations

Zydus Cadila gets USFDA nod to market depression treatment drug in US

Drug firm Zydus Cadila on Saturday said it has received approval from the US health regulator to market Vortioxetine Tablets, used to treat depression, in the American market.

Drug firms Granules India, Jubilant Cadista recall products in US market

Jubilant Cadista is a fully-owned subsidiary of Cadista Holdings Inc, which is a part of the Noida-based Jubilant Life Sciences Company.

Zydus Cadila gets USFDA's approval to market diabetes medication

Drug firm Zydus Cadila on Monday said it has received approval from the US health regulator to market Sitagliptin, a medicine indicated to treat diabetes.

Explained: What FDA full approval to Pfizer-BioNTech vaccine means

The research to develop a safe and effective Covid-19 vaccine was accelerated in 2020

US FDA grants full approval to Pfizer-BioNTech Covid vaccine

The FDA approved the two-dose vaccine for use in people over the age of 16.

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

Drug firm Zydus Cadila said it has received final approval from the US health regulator to market Tofacitinib extended-release tablets, used to treat rheumatoid arthritis, in the American market