Page 11 - Usfda

Glenmark Pharmaceuticals receives USFDA approval for generic Prolixin

Prolixin is a prescription medication used to treat schizophrenia and other mental/mood disorders

USFDA approves new version of diabetes drug Mounjaro for weight loss

A new version of the popular diabetes treatment Mounjaro can be sold as a weight-loss drug, US regulators announced on Wednesday. The US Food and Drug Administration approved Eli Lilly's Zepbound, or tirzepatide. The drug helped dieters lose about a quarter of their body weight, or 60 pounds (27 kilograms), in a recent study. Zepbound is the latest diabetes drug approved for weight loss, joining Novo Nordisk's Wegovy, a high-dose version of its diabetes treatment Ozempic. The FDA approved Lilly's drug for people who are considered obese, with a body mass index of 30 or higher, or those who are overweight with a related health condition, like high blood pressure, high cholesterol or diabetes. The drug should be paired with a healthy diet and regular exercise, the FDA said. In the US, at least 100 million adults and about 15 million children are considered obese. The drug tirzepatide in Zepbound and Mounjaro and semaglutide in Wegovy and Ozempic work by mimicking hormones that kick

Lupin receives approval from the US FDA for its Selexipag for injection

In 2022, sales of the Selexipag Franchise in the US stood at $ 1.1 billion. The sales for January 1 to September 30, 2023, stood at $978 million

Granules India gets USFDA nod for generic drug used to treat heartburn

Granules India Ltd on Thursday said it has received approval from the US health regulator for its generic Esomeprazole Magnesium delayed-release capsules indicated for short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease. The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Esomeprazole Magnesium delayed-release capsules of strengths 20 mg and 40 mg, Granules India said in a regulatory filing. It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Nexium Delayed-Release Capsules, 20 mg and 40 mg, of AstraZeneca Pharmaceuticals LP. Esomeprazole Magnesium capsules are indicated for short-term treatment of heartburn and other symptoms associated GERD, risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults and long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison ...

Zydus unit recalls 7,248 bottles of Oxybutynin Chloride tablets in US

A unit of Zydus Lifesciences is recalling over 7,000 bottles of Oxybutynin Chloride tablets in the US due to manufacturing issues, according to the US Food and Drug Administration (USFDA). As per its latest Enforcement Report, the US health regulator said the drugmaker is recalling 7,248 bottles of Oxybutynin Chloride extended-release tablets, used to treat overactive bladder and urinary conditions, in the US. New Jersey-based Zydus Pharmaceuticals (USA) Inc. is recalling the affected lot due to "Failed Dissolution Specifications", the USFDA stated. The lot was produced at Ahmedabad and distributed in the US by Zydus Pharmaceuticals (USA) Inc, the US health regulator stated. The drug firm initiated the Class II recall on September 21 this year. As per the USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse hea

Lupin receives tentative approval from US FDA for apalutamide tablets

Lupin develops and commercialises a wide range of branded and generic formulations, biotechnology products, and Active Pharmaceutical Ingredients (APIs) in over 100 markets

USFDA rejects proposed Biocon's Insulin Aspart application in CRL

Biotechnology major Biocon on Saturday said the US health regulator has issued a complete response letter for Biocon Biologics' application for Insulin Aspart, a proposed biosimilar for diabetes treatment. The US Food and Drug Administration (USFDA) has issued a Complete Response Letter (CRL) to convey to the company that its initial review of an application is complete, and it cannot approve the application in its present form. "The CRL did not identify any outstanding scientific issues with the product. The CRL references the requirement for a satisfactory resolution of deficiencies from the pre-approval inspection (PAI) of our Malaysia facility for Insulin Aspart, held in August 2022," Biocon spokesperson said in a regulatory filing. The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022 that the agency found to be adequate and indicated that it would require a re-inspection of the Malaysia facility prior to the approval of the ..

US FDA approves NDA for Sun Pharma's alopecia drug Deuruxolitinib

Sun Pharma's NDA submission comprised data from two Phase-III trials, 'THRIVE-AA1' and 'THRIVE-AA2,' involving over 1,200 patients across more than 135 clinical trial sites

Stride Pharma Global receives USFDA approval or Efavirenz, other drugs

The company aims to launch about 60 new products in the next three years in the US market

Marksans Pharma gets USFDA approval for Esomeprazole Magnesium Capsules

The product will be manufactured at Marksans Pharma's formulation manufacturing facility in Goa, India

Indo-US trade ties need to be more ambitious: Ambassador Garcetti

Settling for another deal 'won't be good enough', he says at economic summit

Strides Pharma soars 8% on USFDA nod for drug to treat heart diseases

Meanwhile, Strides said the board is scheduled to meet on September 25, to consider the combine CDMO interests of the group to become one of India's top specialty pharmaceuticals CDMOs

Cipla's US subsidiary InvaGen gets 5 inspectional observations from USFDA

The inspection was a routine current Good Manufacturing Practices (cGMP) inspection and a Pre-Approval Inspection (PAI) for a site transfer product within InvaGen

Aurobindo's Andhra plant receives 1 observation from USFDA after inspection

Aurobindo Pharma on Wednesday said the US health regulator has issued a Form 483 with one observation after inspecting a formulation production facility of its unit in Andhra Pradesh. The US Food and Drug Administration (US FDA) inspected the Unit IV of APL Healthcare Ltd, a wholly-owned subsidiary of the company, in Tirupati district of Andhra Pradesh from September 13-19, 2023, the Hyderabad-based drug major said in a regulatory filing. At the end of the inspection, a Form 483 was issued with one observation which is procedural in nature, it added. "We will respond to the US FDA within the stipulated timelines and work closely with US FDA to close the observation at the earliest," Aurobindo Pharma stated. As per the USFDA a Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. Shares of Aurobindo Pharma were trading ...

Strides soars 11% on USFDA's tentative nod to generic HIV treatment drug

The company said it received a tentative approval from the US health regulator for generic Dolutegravir tablets used in the treatment of HIV

Strides Pharma arm gets USFDA tentative nod for generic HIV treatment drug

Strides Pharma Science Ltd on Thursday said its wholly-owned subsidiary Strides Pharma Global Pte Ltd, Singapore, has received tentative approval from the US health regulator for generic Dolutegravir tablets used in the treatment of HIV. The approval granted by the US Food & Drug Administration (USFDA) is for Dolutegravir tablets of strength 50mg, Strides said in a statement. The Abbreviated New Drug Application (ANDA) is tentatively approved under USFDA's expedited review provision for the President's Emergency Plan for AIDS Relief, thereby qualifying the company to participate in global donor-funded programmes that procure this lifesaving medicine, it said. The medicine is supplied in 126 countries, it added. "As of full year 2022, donor procurement for Dolutegravir 50mg tablets is estimated at a value of USD 35 million. This product further strengthens the available offerings in HIV treatment from Strides," the company said. The approval adds to a list of products that Strides

Strides Pharma gets USFDA approval for generic Sevelamer Carbonate

Strides Pharma Science Ltd on Saturday said its arm, Strides Pharma Global Pte Ltd Singapore, has received approval from the US health regulator for its generic Sevelamer Carbonate for oral suspension indicated for patients with chronic kidney disease on dialysis to prevent dangerous increases in phosphates. The approval by the US Food & Drug Administration (USFDA) is for Sevelamer Carbonate for oral suspension of strengths 0.8g and 2.4g, Strides Pharma Science said in a regulatory filing. The product is bioequivalent and therapeutically equivalent to the reference listed drug Renvela for Oral Suspension, 0.8g and 2.4g of Genzyme, the company said. "The approval completes the company's Sevelamer Carbonate portfolio...The product is a complex generic with limited players having both the tablets and oral suspension," it said adding, the approved medicine will be manufactured at the company's facility in Bengaluru. The Sevelamer Carbonate market for both tablets and oral Suspension ..

Zydus Lifesciences gets USFDA nod for generic acne treatment drug

Zydus Lifesciences on Thursday said it has received approval from the US health regulator to market a generic product to treat acne in the American market. The drug firm has received final approval from the US Food and Drug Administration (USFDA) for Isotretinoin Capsules USP (10 mg, 20 mg 30 mg and 40 mg), it said in a statement. Isotretinoin capsules are used to treat severe cystic acne that has not responded to other treatments. The drug will be manufactured at Zydus' formulation manufacturing facility in Moraiya, Ahmedabad. As per the IQVIA MAT data, Isotretinoin Capsules had annual sales of USD 165 million in the US. Shares of Zydus Lifesciences were trading 0.13 per cent down at Rs 627.35 apiece on the BSE.

Strides Pharma arm gets USFDA approval for generic Mycophenolate Mofetil

Strides Pharma Science Ltd on Wednesday said its wholly-owned arm, Strides Pharma Global Pte. Ltd, Singapore, has received approval from the US health regulator for generic Mycophenolate Mofetil for oral suspension indicated in organ transplant patients to avoid rejection. The approval granted by the US Food & Drug Administration (USFDA) is for Mycophenolate Mofetil for oral suspension of strength 200 mg/ml, Strides Pharma Science said in a regulatory filing. The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), CellCept for oral suspension, 200 mg/m; of Roche Palo Alto, LLC, it added. The approval bolsters the company's Mycophenolate Mofetil portfolio, which already includes numerous products, it added. The product will be manufactured at the company's facility in Bengaluru, Strides said. Mycophenolate Mofetil for oral suspension has a market size of USD 41 million, the company said citing IQVIA data.

Lupin gets USFDA nod to market generic lung disease treatment capsule

Pharma major Lupin Ltd on Tuesday said it received approval from the US health regulator to market its generic Pirfenidone capsules used for the treatment of lung disease known as idiopathic pulmonary fibrosis. The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Pirfenidone capsules of 267 mg strength, Lupin said in a regulatory filing. The drug is the generic equivalent of Esbriet Capsules, 267 mg of Hoffmann La Roche Inc. This product will be manufactured at Lupin's Pithampur facility in India, it added. Pirfenidone capsules had estimated annual sales of USD 95 million in the US, Lupin said citing IQVIA MAT June 2023 data.