Page 16 - Usfda

Lupin gets USFDA approval for Formoterol Fumarate Inhalation Solution

Lupin on Wednesday said it has received approval from the USFDA for Formoterol Fumarate Inhalation Solution, used in treating symptoms of chronic obstructive pulmonary disease. The company has received approval from the US Food and Drug Administration (USFDA) for the product which is a generic version of Mylan Specialty's Perforomist Inhalation Solution, the Mumbai-based drug maker said in a statement. As per IQVIA MAT June 2022 data, the medication had annual sales of around USD 282 million in the US market. Shares of Lupin ended 2.55 per cent down at Rs 677.65 apiece on the BSE on Wednesday.

Wockhardt ties up with various partners to roll out products in US market

Drug firm Wockhardt on Saturday said it has tied up with various partners to roll out products in the US market with its Illinois-based manufacturing plant all set to relieve all workers in a phased manner as part of business restructuring in the US market. The Mumbai-based company said it has engaged multiple US Food and Drug Administration (USFDA) approved manufacturing partners in the US market, after thorough due diligence and inspection of their facilities, to manufacture various products for sale in the US/ North America. "The company is relieving all its staff who were directly engaged by our US subsidiary in its plant in connection with the manufacturing process in a phased manner and in full compliance with the applicable local laws," Wockhardt Ltd said in a regulatory filing. This new arrangement is in the best interest of the company as it will help avoid the manufacturing and quality management cost completely resulting in significant savings in operating and overhead co

Strides Pharma gets USFDA nod for naproxen sodium softgel capsules

Strides Pharma Science Ltd on Thursday said its wholly-owned arm, Strides Pharma Global Pte Ltd, has received approval from the US health regulator for generic naproxen sodium softgel capsules, used to treat pain or inflammation. The approval by the US Food & Drug Administration (USFDA) is for naproxen sodium softgel capsules of 220 mg strength (over the counter), the company said in a regulatory filing. It is bioequivalent and therapeutically equivalent to the reference-listed drug, naproxen sodium capsules, 220 mg of Bionpharma Inc, it added. The product will be manufactured at the company's Bengaluru facility. Naproxen sodium softgel capsules is a nonsteroidal anti-inflammatory drug used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps, the company said. Strides said it is focusing on building a private label business in the US by leveraging its portfolio of products across soft gels, .

Lupin receives USFDA nod for rufinamide tablets to treat seizures

Pharmaceuticals firm Lupin Ltd on Thursday said it has received approval from the US health regulator to market its generic rufinamide tablets used in the treatment seizures. The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of rufinamide tablets of strengths 100 mg, 200 mg, and 400 mg, Lupin said in a statement. These are the generic equivalent of banzel tablets of same strengths of Eisai Inc, it added. The product will be manufactured at Lupin's facility in Goa, the company said. Rufinamide tablets had estimated annual sales of USD 164 million in the US, Lupin said citing IQVIA MAT June 2022 data.

USFDA approves Aurobindo Pharma owned Eugia's generic Vasopressin injection

Aurobindo Pharma Ltd on Tuesday said its wholly-owned arm Eugia Pharma Specialties Ltd has received final approval from the US health regulator for its generic version of Vasopressin injection

Aurobindo Pharma's Andhra unit gets Form 483 with 3 USFDA observations

Aurobindo Pharma on Tuesday said the US health regulator has issued Form 483 with three observations after inspecting its manufacturing facility at Pydibhimavaram in Andhra Pradesh. As per US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The Pydibhimavaram unit was classified as OAI (official action indicated) on May 17, 2019, and subsequently given a warning letter on June 20, 2019 by the USFDA, Aurobindo Pharma said in a regulatory filing. Subsequently, the company said it has responded to the warning letter and carried out the committed corrections and the USFDA authorities inspected the facility from July 25 to August 2, 2022. "At the end of the inspection, we have been issued a Form 483 with three observations and none of these observations are related ..

Cipla Q1 net dips 4% to Rs 686 cr, revenue down 2% on tapering Covid sales

Domestic revenue dips 8.4% as Covid-19 share of branded prescription business normalises; North American business up 10% to $155 million

Alembic Pharma receive USFDA approval to market drug for skin treatment

Alembic Pharmaceuticals on Friday said its subsidiary has received approval from the US health regulator to market medication for treating actinic keratoses

Glenmark Pharma arm gets final USFDA nod for birth control capsules

Glenmark Pharmaceuticals Ltd on Friday said its US arm has received final approval from the US health regulator for its generic Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate birth control capsules. The approval granted by the US Food & Drug Administration (USFDA) to Glenmark Pharmaceuticals Inc is for Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules of strength 1 mg/20 mcg, the company said in a statement. It is the generic version of Taytulla capsules of Allergan Pharmaceuticals International Ltd, it added. Citing IQVIA sales data for the 12 months ended May 2022, the company said the Taytulla Capsules market achieved annual sales of approximately USD 85.9 million.

Lupin gets USFDA approval for generic blood pressure lowering drug

Drug firm Lupin on Monday said it has received an approval from the US Health regulator to market generic medication to treat high blood pressure.

Zydus gets USFDA approval to market generic antifungal medication

Zydus Lifesciences on Monday said its subsidiary has received approval from the US health regulator to market antifungal Efinaconazole Topical solution

Dr Reddy's gains over 3% on new drug launch in the US market

The company launched its generic version of fesoterodine fumarate extended-release tablets that can be used for treating overactive bladder in the US market.

Aurobindo Pharma receives Sebi's warning letter over ongoing USFDA audit

The letter is in regards to certain disclosures made by the company on the ongoing USFDA audit of company's Unit-1 and observations made by the USFDA between the period 2019 to 2022

US FDA authorizes Covid-19 vaccines for kids as young as 6 months

The US Food and Drug Administration (FDA) has authorized emergency use of the Moderna and Pfizer-BioNTech Covid-19 vaccines for children as young as 6 months, the first for kids in this age group

USFDA authorises first coronavirus shots for infants, preschoolers

The Food and Drug Administration's action follows its advisory panel's unanimous recommendation for the shots from Moderna and Pfizer

US FDA advisers approve Moderna, Pfizer vaccines for kids under 5

COVID-19 shots for US infants, toddlers and preschoolers moved a step closer Wednesday

Alembic Pharma gets USFDA nod for cancer treatment drug in US market

Alembic Pharmaceuticals on Friday said it has received approval from the US health regulator to market Dasatinib tablets, used to treat certain types of cancers, in the American market

India's Serum Institute to make Novavax's Covid vaccine for US market

The company has indicated in the first quarter earnings call that it has reached a major milestone in its pathway to an emergency use authorisation from the US Food and Drugs Administration

Lupin receives tentative approval from USFDA to market Ivacaftor tablets

The product is the generic equivalent of Vertex Pharmaceuticals' Kalydeco tablets, Lupin said in a statement

Ahmedabad-based Zydus gets USFDA approval to market generic acne drug

A combination of Adapalene (a retinoid) and Benzoyl Peroxide (an antibiotic and skin-peeling agent), the gel is used to decrease the number and severity of acne pimples