Page 17 - Usfda

USFDA rush after 2-year lull: 20-30% new products may be open to inspection

The last two years saw limited physical inspections due to travel restrictions during the pandemic

TMS Ep170: Ambuja and ACC, Sonam Wangchuk, IPO size, USFDA's Form 483

Why are top Indian companies vying for Ambuja & ACC? Can Sonam Wangchuk's innovation clear Delhi's air? Market volatility to make companies trim their IPO size? What is USFDA's Form 483? Answers here

Alembic gets final USFDA nod for medication to treat bronchoconstriction

Alembic Pharmaceuticals Ltd on Wednesday said it has received final approval from the US health regulator for its generic version of Arformoterol Tartrate inhalation solution indicated for long-term treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease. The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) for Arformoterol Tartrate inhalation solution is for strength of 15 mcg (base)/2 mL unit-dose vial, the company said in a statement. The approved ANDA is therapeutically equivalent to the reference-listed drug product (RLD), Brovana inhalation solution, 15 mcg/2 mL, of Sunovion Pharmaceuticals Inc, it added. Arformoterol Tartrate inhalation solution is indicated for long-term, twice daily administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, the company said. This ANDA has ...

Sun Pharma's Halol unit gets 10 observations under USFDA's Form 483

Plant's OAI status is unchanged, hinting at status quo; Sun Pharma says will respond to observations within 15 days

Sun Pharma slips over 2% after USFDA issues observations for Halol facility

In the past five days, the stock has fallen over 5 per cent. In comparison, the S&P BSE Sensex declined 3.75 per cent during the same period

Glenmark gets tentative nod from USFDA for generic psoriasis foam

Glenmark Pharmaceuticals on Monday said its US-based arm has received tentative approval from the US health regulator for its generic Calcipotriene and Betamethasone Dipropionate foam used to treat psoriasis. The tentative approval granted to Glenmark Pharmaceuticals Inc, USA (Glenmark) by the US Food & Drug Administration (USFDA) is for Calcipotriene and Betamethasone Dipropionate foam of strength 0.005 per cent/0.064 per cent, the company said in a statement. It is the generic equivalent of Leo Pharma AS' Enstilar foam, it added. Citing IQVIATM sales data for the 12 months ended March 2022, the company said Enstilar foam, 0.005 per cent/0.064 per cent achieved annual sales of approximately USD 115.2 million. Glenmark said its current portfolio consists of 174 products authorised for distribution in the US marketplace and 48 abbreviated new drug applications (ANDAs) are pending approval with the USFDA.

Alembic arm receives final USFDA approval for generic fever blisters drug

Alembic Pharmaceuticals on Wednesday said its wholly-owned arm Aleor Dermaceuticals has received final approval from the US health regulator for its generic Docosanol cream indicated for cold sore/fever blisters on the face or lips. The final approval granted by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Docosanol cream, 10 per cent (over the counter), the company said in a regulatory filing. The approved ANDA is therapeutically equivalent to the reference listed drug product Abreva Cream, 10 per cent (OTC) of GlaxoSmithKline Consumer Healthcare, it added. Citing IQVIA data, Alembic said Docosanol cream, 10 per cent (OTC) has an estimated market size of USD 60 million for 12 months ending December 2021. Alembic has received a cumulative total of 166 ANDA approvals (142 final approvals and 24 tentative approvals) from the USFDA, it added.

Aurobindo, Sun Pharma, Jubilant recall products in US market: USFDA

Leading drug firms Aurobindo Pharma, Sun Pharma and Jubilant are recalling different products in the US market for various reasons

Alembic gets USFDA nod to market lvabradine used in treating heart failure

Alembic Pharmaceuticals on Wednesday said it has received approval from the US health regulator to market lvabradine tablets, used to treat heart failure, in the American market. The company has received tentative approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for lvabradine tablets (5 mg and 7.5 mg), Alembic Pharmaceuticals said in a regulatory filing. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Corlanor Tablets, 5 mg and 7.5 mg, of Amgen Inc. (Amgen). lvabradine Tablets are indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure. lvabradine Tablets are also indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate. According to IQVIA, ...

Lupin receives USFDA approval for anti-depressant drug

It is the generic equivalent of Pristiq, extended-release tablets, 25 mg of PF PRISM C.V, it added

Lupin's New Jersey facility gets 13 US FDA observations

The observations do not, however, imply any restriction on supplies

FDA authorises second booster of Pfizer/BioNTech, Moderna Covid shots

FDA authorises another booster dose of the Pfizer or Moderna Covid vaccine for people age 50 and up

Alembic Pharma targets 10-12 product filings from Karkhadi facility

Resolution of the observations made by the USFDA (for which Alembic has already responded to the regulator) is critical for Alembic's US business

Unichem Laboratories gets USFDA approval for generic Nebivolol tablets

Unichem Laboratories on Wednesday said it has received approval from the US health regulator to market its generic version of Nebivolol tablets indicated for the treatment of hypertension

Zydus Lifesciences gets 3 observations from USFDA for Vadodara plant

Zydus Lifesciences on Thursday said the US health regulator has issued three observations after inspecting its Jarod (Vadodara) based manufacturing facility. The US Food and Drug Administration (USFDA) inspected the injectable facility from February 24 to March 10, 2022. The inspection closed with three observations, the drug firm said in a regulatory filing. "We are confident of addressing and resolving the issues to the satisfaction of USFDA. We remain committed to building a quality culture across our entire manufacturing network, and are committed to remain compliant with high standards of good manufacturing practices across our network," Zydus Lifesciences stated. As per the US health regulator, an FDA Form 483 (observation) is issued to a firm's management at the conclusion of an inspection when investigators have observed any conditions that in their judgment may constitute violations of Food Drug and Cosmetic (FD&C) Act and related Act.

Zydus Lifesciences gets USFDA nod for generic drug to treat chest pain

Zydus Lifesciences on Wednesday said it has received approval from the US health regulator to market Nitroglycerin Sublingual tablets, used to treat chest pain, in the American market.

Alembic Pharmaceuticals joint venture gets USFDA nod for anti-fungal drug

Alembic Pharmaceuticals Ltd on Tuesday said its joint venture, Aleor Dermaceuticals Ltd (Aleor), has received final approval from the US health regulator for its generic version of Nystatin and Triamcinolone Acetonide ointment used for the treatment of cutaneous candidiasis. Cutaneous candidiasis is an infection of the skin and nails caused by the candida fungus. The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Nystatin and Triamcinolone Acetonide Ointment of strength 100,000 units/gram, Alembic Pharmaceuticals said in a regulatory filing. The approved ANDA is therapeutically equivalent to the reference-listed drug product (RLD) Nystatin and Triamcinolone Acetonide ointment of Taro Pharmaceuticals USA Inc, it added. The company further said Nystatin and Triamcinolone Acetonide ointment is indicated for the treatment of cutaneous candidiasis. It has been demonstrated that the nystatin-steroid combination provides ...

Virtual audits will not replace physical inspection, says USFDA

Surprise audits of manufacturing sites too are on the cards

Zydus gets regulator nod to market generic diabetes drug in American

Zydus Group on Wednesday said it has received final approval from the US health regulator to market diabetes medication Dapagliflozin tablets in the American market. The drug maker has received final approval from the US Food and Drug Administration (USFDA) to market the drug in the strengths of 5 mg and 10 mg. Dapagliflozin is used with a proper diet and exercise programme to control high blood sugar in people with type 2 diabetes. The drug also lowers the risk of heart failure in adults with type 2 diabetes with heart disease. It is also used to lower the risk of further worsening of kidney disease, end-stage kidney disease (ESKD), death due to cardiovascular disease, and hospitalisation for heart failure in adults with chronic kidney disease. Dapagliflozin works by increasing the removal of sugar by kidneys. The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad, Zydus Group stated. The group now has 328 approvals and has so far fi

Lupin receives USFDA approval for antibiotic Solosec

Lupin Ltd on Thursday said it has received approval from the US health regulator for its supplemental New Drug Application (sNDA) for usage of its antibiotic Solosec.