Page 20 - Usfda
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.
 "Zydus Cadila gets tentative nod from USFDA to market generic acne drug")
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
 "Lupin gets tentative nod from USFDA to market generic Brexpiprazole tablets")
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
 "US FDA okays Covid booster shot for people above 65, 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
 "Glenmark Pharma gets USFDA nod for generic antibiotic cream")
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.
 "Zydus Cadila gets USFDA nod to market depression treatment drug in US")
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.
 "Drug firms Granules India, Jubilant Cadista recall products in US market")
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
 "Explained: What FDA full approval to Pfizer-BioNTech vaccine means")
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.
 "US FDA grants full approval to Pfizer-BioNTech Covid vaccine")
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
 "Zydus Cadila gets USFDA nod for arthritis drug with 180-days exclusivity")
USFDA's drug approvals for Indian firms halved in H1CY21: Report
ANDAs granted have halved in H12021, compared to pre-pandemic levels
 "USFDA's drug approvals for Indian firms halved in H1CY21: Report")
Zydus Cadila gets tentative approval from USFDA for cancer drug
Shares of Cadila Healthcare, the listed entity of the group closed at Rs 531.35 per scrip on BSE, down 0.10 percent from its previous close.
Lupin gets tentative nod from USFDA to market partial-onset seizures drug
Drug firm Lupin on Monday said it has received tentative nod from the US health regulator to market its generic Brivaracetam tablets used for the treatment of partial-onset seizures
Top headlines: India sticks to growth forecast; Kerala struggles with Covid
Business Standard brings to you the top headlines on Friday
 "Top headlines: India sticks to growth forecast; Kerala struggles with Covid")
USFDA okays Biocon insulin Semglee as first interchangeable biosimilar drug
Semglee may now be substituted for Sanofi's Lantus by a pharmacist in the US
 "USFDA okays Biocon insulin Semglee as first interchangeable biosimilar drug")
Caplin Point jumps 19%, hits record high; stock soars 37% in seven days
A combined 5.8 million equity shares, representing 7.6 per cent of the total equity of Caplin Point Laboratories, had changed hands on NSE and BSE till 12:56 pm
 "Caplin Point jumps 19%, hits record high; stock soars 37% in seven days")
Zydus Cadila gets tentative approval from USFDA to market cancer drug
Drug firm Zydus Cadila on Wednesday said it has received tentative approval from the US health regulator to market Ibrutinib tablets used in the treatment of certain types of cancers.
Zydus gets USFDA nod to market generic HIV infection treatment tablets
The drug will be manufactured at the group's formulation manufacturing facility at SEZ, Ahmedabad
 "Zydus gets USFDA nod to market generic HIV infection treatment tablets")