Page 11 - Usfda

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.

Torrent Pharmaceuticals gets EIR from USFDA for Gujarat's Dahej facility

The Dahej facility manufactures Active Pharmaceutical Ingredients (APIs) and formulations for Torrent Pharma's international markets

USFDA grants VAI classification to Torrent's Gujarat manufacturing site

The US health regulator has granted Voluntary Action Indicated classification to Torrent Pharmaceutical's manufacturing site in Dahej, Gujarat. A VAI classification means objectionable conditions or practices were found but the agency is not prepared to take or recommend any administrative or regulatory action. As per the information available on its website, the United States Food and Drug Administration (USFDA) has granted Voluntary Action Indicated (VAI) classification to the plant. The Dahej site was earlier placed under 'Official Action Indicated (OAI)' classification based on a March 2019 inspection outcome. OAI means "objectionable conditions were found and regulatory administrative sanctions by FDA are indicated" during inspections. The Dahej site was re-inspected by the USFDA between May 17 and May 25, 2023 and the officials had issued Form 483 with two observations. Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has ..

Lupin receives USFDA approval for generic blood pressure lowering drug

Pharma major Lupin Ltd on Wednesday said it has received approval from the US health regulator to market its generic Metoprolol Succinate extended-release tablets used for lowering blood pressure. The approval by the US Food and Drug Administration (USFDA) for the abbreviated new drug application is for Metoprolol Succinate extended-release tablets of strengths 25 mg, 50 mg, 100 mg, and 200 mg, Lupin said in a regulatory filing. These are generic equivalent of Toprol-XL Tablets of Sequel Therapeutics, LLC. This product will be manufactured at Lupin's Pithampur facility in India, the company said. Metoprolol Succinate extended-release tablets had an estimated annual sales of USD 305 million in the US, the company said citing IQVIA MAT June 2023 data.

Pharma major Lupin gets USFDA approval for its generic antibiotic

Pharma major Lupin Ltd on Monday said it has received approval from the US health regulator to market its generic antibiotic Doxycycline Hyclate delayed-release tablets used to treat bacterial infections. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Doxycycline Hyclate delayed-release tablets of strengths 50 mg, 60 mg, 75 mg, 80 mg, 100 mg, 120 mg, 150 mg, and 200 mg, Lupin said in a regulatory filing. This product will be manufactured at Lupin's Pithampur facility in India, it added. Doxycycline Hyclate Delayed-Release tablets had estimated annual sales of USD 9 million in the US, the company said citing IQVIA MAT June 2023 data.

USFDA issues warning letter to Intas Pharma for lapses at Sanand plant

The US health regulator has pulled up Intas Pharmaceuticals for manufacturing lapses, including failure of its quality control unit to ensure CGMP compliance, at its Sanand-based manufacturing plant. In a warning letter dated July 28, 2023, the US Food and Drug Administration (USFDA) pointed out various manufacturing lapses at the plant. "This warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals," the USFDA said. It further said: "Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated.." The USFDA inspected the manufacturing facility from November 22 to December 2, 2022. A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. The USFDA said the company "failed to exercise its responsibility to ensure drug products manufactured are

Zydus Lifesciences gets USFDA nod for generic rheumatoid arthritis drug

Zydus Lifesciences Ltd on Thursday said it has received final approval from the US health regulator to manufacture and market its generic Indomethacin suppositories indicated for moderate to severe rheumatoid arthritis. The approval by the US Food and Drug Administration (USFDA) is for manufacturing and marketing of Indomethacin suppositories of 50mg strength, the company said in a regulatory filing. The company has been granted 180-day CGT (competitive generic therapy) exclusivity to market this product, it added. As per the USFDA, it may designate a drug as a CGT after determining that there is inadequate generic competition for that drug. "We are happy to leverage the CGT approval pathway of the USFDA to provide patients with expanded access to a product with limited competition," Zydus Lifesciences Managing Director Dr Sharvil Patel said. Zydus said Indomethacin suppositories is a non-steroidal, anti-inflammatory drug indicated for moderate to severe rheumatoid arthritis inclu

Lupin gets USFDA approval to market generic skin treatment medication

Lupin on Wednesday said its American subsidiary has received an approval from the US health regulator to market a generic product used for treatment of skin issues. New Jersey-based Novel Laboratories Inc has received the approval from the US Food and Drug Administration (USFDA) for Fluocinolone Acetonide Topical Oil, Lupin said in a statement. The product is the generic version of Hill Dermaceuticals Inc's Derma-Smoothe/FS Topical Oil. Lupin said the product will be manufactured at its Somerset facility in the US. As per the IQVIA MAT March 2023 data, Fluocinolone Acetonide Topical Oil had estimated annual sales of USD 9 million in the US. Lupin shares were trading 0.67 per cent down at Rs 981.65 apiece on the BSE.