Page 18 - Usfda

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.

Zydus Pharma gets final USFDA approval to market Roflumilast tablets

Zydus, being one of the first applicants for Roflumilast Tablets, 500 mcg, is eligible for 180 days of shared generic drug exclusivity

Granules India gets USFDA approval for generic antidepressant drug

Drug firm Granules India on Thursday said it has received approval from the US health regulator to market Bupropion Hydrochloride extended-release tablets, an antidepressant medication, in the American market. Granules Pharmaceuticals, Inc (GPI), a wholly-owned subsidiary of the company, has received approval from the US Food & Drug Administration (USFDA) to market the product in strengths of 150 mg and 300 mg, the Hyderabad-based drug firm said in a statement. The company's product is a generic version of Bausch Health US, LLC's Wellbutrin XL extended-release tablets. Bupropion Hydrochloride is used as an antidepressant medication to treat major depressive disorder and seasonal affective disorder. "We are pleased to receive approval of Bupropion Hydrochloride (XL) tablet product within first review cycle of 10 months from filing date. This product will be a valuable addition to our growing modified release product portfolio in the US market," GPI Executive Director Priyanka ...

Pfizer applies to USFDA for two-dose vaccine for kids under 5 years

The request for emergency authorisation comes as the highly contagious Omicron variant has led to record numbers of infections

Glenmark gets nod from US Food & Drug Administration for generic drug

Glenmark Pharmaceuticals on Friday said its US-based unit has received approval from the US health regulator to market Metronidazole Vaginal gel, in the American market. The drug firm has received final approval by the United States Food & Drug Administration (USFDA) for its product which is a generic version of Bausch Health US LLC's MetroGel-Vaginal, the drug firm said in a statement. According to IQVIA sales data for the 12-month period ending November 2021, the MetroGel-Vaginal Gel achieved annual sales of approximately around USD 60.4 million. Glenmark's current portfolio consists of 173 products authorised for distribution in the US marketplace and 46 ANDA's pending approval with the USFDA. In addition to these internal filings, the drug firm continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio, Glenmark noted.

USFDA pulls up Aurobindo Pharma for manufacturing lapses at API plant

The US Food and Drug Administration (USFDA) has issued a warning letter to Aurobindo Pharma for violating current good manufacturing practice norms at its Telangana-based plant.

USFDA limits use of Regeneron, Lilly Covid-19 antibody treatments

The Food and Drug Administration said the treatments are currently not cleared for use in any US states or territories, but may be authorized in certain regions

FDA may authorise Pfizer's Covid vax for kids under 5 in Feb: Fauci

The US Food and Drug Administration (FDA) is likely to approve Pfizer's Covid vaccine for children under 5 years of age in February, White House chief medical advisor Anthony Fauci has said.

Zydus gets final USFDA nod to market generic version of Vigabatrin tablets

Cadila Healthcare said group firm Zydus has received final approval from the US health regulator to market its generic version of Vigabatrin tablets

Aurobindo Pharma gets warning letter from USFDA for API facility

Aurobindo Pharma on Friday said it has received a warning letter from the US health regulator for its Hyderabad-based Unit I, an API manufacturing facility.

Glenmark gets USFDA nod for nasal spray to treat seasonal allergic rhinitis

Glenmark Pharma on Friday said its subsidiary has received approval from the US health regulator to market Ryaltris, a nasal spray for the treatment of seasonal allergic rhinitis.

Alembic Pharmaceuticals gets USFDA nod to market generic product

Alembic Pharmaceuticals on Monday said it has received approval from the US health regulator to market generic Dronedarone tablets, which is used to reduce risk of hospitalisation for atrial fibrillation, 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 its medication in strength of 400 mg, the drug maker said in a statement. The tentatively approved ANDA is therapeutically equivalent to Sanofi-Aventis' Reference Listed Drug (RLD) product Multaq Tablets, 400 mg. Dronedarone is indicated to reduce the risk of hospitalisation for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation. Cumulatively, the company has so far received 158 ANDA approvals from USFDA.

USFDA rejects Biocon, Viatris application for Insulin Aspart

The company will respond to the CRL to satisfy the FDA's requests

Alembic Pharma gets tentative USFDA approval for depressive disorder drug

Alembic Pharmaceuticals Ltd on Friday said it has received tentative approval from the US health regulator for its generic Vortioxetine tablets indicated for the treatment of the major depressive disorder. The tentative approval granted by the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Vortioxetine tablets of strengths in 5 mg, 10 mg, 15 mg and 20 mg, the company said in a statement. These are therapeutically equivalent to the reference listed drug product (RLD) Trintellix tablets 5 mg, 10 mg, 15 mg, and 20 mg of Takeda Pharmaceuticals, USA, Inc, it added. Citing IQVIA data, the company said these Vortioxetine tablets have an estimated market size of USD 1,249 million for twelve months ending September 2021. Alembic, however, said it is currently in litigation with H Lundbeck in the Court of appeals for the Federal Circuit and the launch of the product will depend on litigation outcome. "It is possible that our ANDA may not be ...

Alembic gets USFDA nod for generic drug to treat bacterial infections

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Doxycycline Hyclate delayed-release tablets