Page 11 - Usfda

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.

Glenmark Pharmaceuticals gets USFDA nod to market generic diabetes drug

Glenmark Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market a generic diabetes drug in the American market. The company has received final approval from the US Food & Drug Administration (US FDA) for Saxagliptin Tablets (2.5 mg and 5 mg), the generic version of AstraZeneca's Onglyza1 tablets, the Mumbai-based drug maker said in a statement. According to IQVIATM sales data, for the 12-month period ending June 2023, the Onglyza tablets (2.5 mg and 5 mg) achieved annual sales of around USD 100.7 million. Glenmark said its current portfolio now consists of 184 products authorized for distribution in the US market and 49 abbreviated new drug applications (ANDAs) are pending approval with the US FDA.

Tornado damage to Pfizer plant unlikely to cause supply shortages: US FDA

Most of the destruction from a tornado that tore through eastern North Carolina on Wednesday and struck a large Pfizer pharmaceutical plant affected its storage facility, rather than its medicine production areas, the company said on Friday. The drugmaker's ability to salvage production equipment and other essential materials could mitigate what experts feared would be a major blow to an already strained system as the United States grapples with existing drug shortages. We do not expect there to be any immediate significant impacts on supply given the products are currently at hospitals and in the distribution system, US Food and Drug Administration Commissioner Robert Califf said on Friday. An EF3 tornado touched down on Wednesday near Rocky Mount, ripping the roof off a Pfizer factory responsible for producing nearly 25 per cent of the American pharmaceutical giant's sterile injectable medicines used in US hospitals, according to the drugmaker. Pfizer said on Friday that a wareho

Dr Reddy's application for biosimilar candidate accepted for USFDA's review

Dr Reddy's Laboratories on Wednesday said its biologics licence application for its proposed biosimilar rituximab candidate has been accepted for a substantive review by the US Food and Drug Administration (USFDA). This closely follows acceptance of the rituximab biosimilar dossier for review by two other regulatory agencies -- the European Medicines Agency (EMA) and the UK's Medicines and Healthcare products Regulatory Agency (MHRA). Rituximab is used to treat certain autoimmune diseases and types of cancer. "This milestone underscores our capability for global clinical development of high-quality biosimilar products for highly regulated and global markets," Dr Reddy's Global Head of Biologics Jayanth Sridhar said in a statement. It also reinforces the potential of the product as a safe and effective treatment option for patients across the globe, he added. Development and commercialisation of biological drugs is an important growth lever for the company's business, Sridhar ...

Lupin gets USFDA establishment inspection report for Pithampur facility

Drug firm Lupin on Tuesday said it has received an Establishment Inspection Report from the US health regulator for its Pithampur Unit-2 manufacturing facility. The Establishment Inspection Report (EIR) was issued after the last inspection of the facility, which manufactures oral solids and ophthalmic dosage forms, conducted from March 21-29, 2023, the Mumbai-based drug maker said in a statement. The US Food and Drug Administration (FDA) issues an EIR on closure of inspection of an establishment that is the subject of an FDA or FDA-contracted scrutiny. The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI). According to the the USFDA, a VAI means that objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. "This is a significant milestone as we build back our reputation of being best-in-class in quality and compliance. We look forward to ne

Lupin gets USFDA approval for generic version of Cyanocobalamin nasal spray

Pharma major Lupin Ltd on Monday said it has received approval from the US health regulator for its generic version of Cyanocobalamin nasal spray. The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Cyanocobalamin nasal spray of strength 500 mcg/spray (one spray per device), Lupin said in a statement. Cyanocobalamin nasal spray is used to maintain normal vitamin B12 blood levels in patients with pernicious anaemia. "This product will be manufactured at Lupin's Somerset facility in the US," the company added. Cyanocobalamin nasal spray had estimated annual sales of USD 69 million in the US, Lupin said, citing IQVIA MAT March 2023 data.

Lupin receives US regulator's approval for Cyanocobalamin nasal spray

The nasal spray manufactured by Lupin is a generic version of Nascobal nasal spray

USFDA observations in 2022 focus on ancillary infra, written procedures

45% observations in 2022 around unavailability of written procedures and facility maintenance, ancillary infrastructure

Facing higher scrutiny, IPA plans monthly meetings with members on quality

Data suggests that Indian sites received fewer OAIs in the first six months of 2023

USFDA emphasises on response over perfection in inspections: Sarah McMullen

McMullen stressed the importance of a robust quality system