Page 5 - Usfda

Aurobindo Pharma share down 4% as arm gets 10 observations from USFDA

Aurobindo Pharma's subsidiary Apitoria Pharma has received 10 observations from the USFDA for its API manufacturing facility in Telangana

Zydus gets USFDA approval to produce its generic prostate cancer drug

Zydus Lifesciences on Saturday said it has received approval from the US health regulator to produce generic prostate cancer treatment drug. The company has received approval from the US Food and Drug Administration (USFDA) to manufacture Enzalutamide capsules (40 mg), it said in a regulatory filing. Enzalutamide capsules are androgen receptor inhibitors indicated for the treatment of patients with metastatic castration-resistant prostate cancer. The drug will be produced at the group's manufacturing site in Moraiya, Ahmedabad, Zydus said. As per IQVIA MAT July 2024 data, Enzalutamide capsules (40 mg) had annual sales of USD 869.4 million in the US. The group now has 400 approvals and has filed over 465 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04.

US FDA approves Bristol Myers' Squibb drug for treating schizophrenia

Bristol Myers obtained the drug Cobenfy, also known as KarXT, through its $14 billion takeover of Karuna Therapeutics last year

Eli Lilly wants records of people who took copies of its weight-loss drug

The Food and Drug Administration has listed an ongoing shortage of Lilly's medicines since December 2022

Strides Pharma Science gets USFDA nod for generic antidepressant tablets

Strides Pharma Science Ltd on Monday said its arm has received approval from the US health regulator for its generic version of antidepressant Fluoxetine tablets. The approval granted by the US Food & Drug Administration (USFDA) to wholly owned subsidiary Strides Pharma Global Pte. Ltd, Singapore, is for Fluoxetine tablets of strength 60 mg, Strides Pharma Science said in a regulatory filing. The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Fluoxetine tablets, 60 mg, of TWi Pharmaceuticals, Inc, it added. The Fluoxetine tablets will be manufactured at the company's facility in Puducherry, Strides said. With the approval of the Fluoxetine Tabs 60 mg strength, the company is now positioned to offer a complete portfolio of Fluoxetine across capsules and tablets in 10 mg, 20 mg, and 60 mg strengths, it added. The addition of the Fluoxetine tablets 60 mg will allow for enhanced flexibility in dosing, catering to a broader spectrum of ...

USFDA approves injectable version of Roche's multiple sclerosis therapy

The therapy is already approved as an infusion or IV therapy for multiple sclerosis, which is given twice a year, under the brand name Ocrevus

Dr Reddy's gets USFDA's inspection report for Srikakulam-based API plant

Dr Reddy's Laboratories on Friday said it has received the establishment inspection report (EIR) from the US health regulator for its active pharmaceutical ingredient manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh. The US Food and Drug Administration (USFDA) has classified the inspection as Voluntary Action Indicated (VAI) and concluded that the inspection is close, the Hyderabad-based drug maker said in a statement. As per USFDA, VAI means that objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. On June 7 this year, Dr Reddy's had stated that the US health regulator has issued Form 483 with four observations after inspecting its Srikakulam-based facility. Shares of the company on Friday ended 0.42 per cent down at Rs 6,669.75 apiece on the BSE.

Alembic Pharma shares jump 5% after USFDA approval; check details here

Alembic Pharma share price surged up to 5 per cent at Rs 1,170.60 per share on the BSE in Thursday's intraday trade

Dr Reddy's, Lupin recall products in US due to manufacturing issues: USFDA

Dr Reddy's Laboratories and Lupin are recalling products in the US due to manufacturing issues, as per the US Food and Drug Administration (USFDA). Dr Reddy's Laboratories Inc, a subsidiary of Hyderabad-based drug firm, is recalling Ibuprofen tablets in multiple strengths, the US health regulator said in its latest enforcement report. Ibuprofen tablets are indicated for pain relief and fever. New Jersey-based Dr Reddy's Laboratories Inc. is recalling 1,03,298 bottles (800 mg); 31,802 bottles (600 mg); and 14,940 bottles (400 mg) of Ibuprofen tablets in the US market, USFDA said. The company is recalling the affected lot due to "Failed impurities/degradation specifications," it added. "Results for unknown impurity were 0.13 per cent and 0.11 per cent, respectively, exceeding the 0.10 per cent specification limit," USFDA noted. The company initiated the Class II nationwide recall on August 6 this year. USFDA stated that Lupin is recalling 4,554 bottles of Cefixime for Oral Suspen

Zydus Lifesciences gets USFDA nod to mkt Scopolamine transdermal system

Zydus Lifesciences Ltd on Friday said it has received the final approval from the US Health regulator to market its Scopolamine transdermal system indicated to prevent nausea and vomiting under different circumstances. The approval granted by the US Food and Drug Administration (USFDA) is to market the Scopolamine transdermal system of dosage 1 mg/3 days, Zydus Lifesciences said in a regulatory filing. The Scopolamine transdermal system will be produced at the group's transdermal manufacturing site at SEZ, Matoda, Ahmedabad, it added. Scopolamine transdermal System is indicated to prevent nausea and vomiting after anaesthesia, narcotic pain medicines, and surgery. It is also used to prevent nausea and vomiting caused by motion sickness. "This is the fifth abbreviated new drug application (ANDA) approval for Zydus in the transdermal portfolio, leveraging the group's strengths in the manufacturing of complex drug device dosage forms," the company said. Scopolamine Transdermal System

Aurobindo, others recall products in US market over production issue: USFDA

Drug makers Aurobindo Pharma, Glenmark and FDC are recalling products in the US due to manufacturing issues, as per the US Food and Drug Administration (USFDA). Aurobindo Pharma USA Inc -- a unit of Hyderabad-based drug major -- is recalling 240 bottles of pain-relieving medication Healthy Living Acetaminophen, Aspirin (NSAID) and caffeine tablets. As per the latest enforcement report of USFDA, the company is recalling the affected lot due to "Missing Label". Some bottles are missing the manufacturer's label that includes the drug facts information, the US health regulator said. The New Jersey-based Aurobindo Pharma USA Inc initiated the Class 1 recall on July 11, it said. As per the US health regulator, a Class I recall pertains to defective products that can cause serious health problems. Similarly, a US-based subsidiary of Glenmark Pharmaceuticals is recalling 2,404 bottles of Indomethacin Extended-Release Capsules, produced at a Madhya Pradesh plant, due to "Failed Dissolutio

USFDA pulls up Eugia for manufacturing lapses at its Telangana plant

The US health regulator has pulled up Aurobindo Pharma's subsidiary Eugia for manufacturing lapses at its Telangana-based plant. In a warning letter to Eugia Pharma Specialities CEO Yugandhar Puvvala, the US Food and Drug Administration (USFDA) pointed out that the company failed to ensure the accuracy of data for production and process simulation. "Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards," USFDA stated. The US health regulator said it inspected the Patancheru (Mandal), Sangareddy, Hyderabad-based plant from January 22 to February 2, 2024. "You failed to ensure the accuracy of data in records for both production and process simulations (media fills)," USFDA noted. Besides, the operators also falsified environmental monitoring records for the multiple aseptic filling lines, including for viable active air samples and non-viable particle counts which

Indoco Remedies stock soars over 5% on USFDA approval for opioids drug

Indoco Remedies stock surged up to 5.53 per cent at Rs 358.60 per share on the BSE in Wednesday's intraday deals

US FDA declines to approve Regeneron's therapy for common blood cancer

FDA, in a so-called 'complete response letter', said that the sole issue identified for approval is related to findings from a pre-approval inspection at a third-party manufacturer

Alembic Pharma gets approval from US FDA to market generic medication

Alembic Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market a generic product indicated for prophylaxis of deep vein thrombosis. The company has received approval from the US Food and Drug Administration (USFDA) to market Dabigatran Etexilate Capsules (110 mg), the drug firm said in a regulatory filing. Dabigatran Etexilate Capsules are indicated for prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery. The approved product is therapeutically equivalent to Boehringer Ingelheim Pharmaceuticals Inc's Pradaxa Capsules (110 mg). The company said it now has a cumulative total of 211 ANDA (abbreviated new drug application) approvals from the USFDA. Shares of the company on Tuesday closed 3.17 per cent down at Rs 1,076 apiece on the BSE.

Dr Reddy's Labs shares drop after US FDA gives VIA tag to Vizag facilities

Shares of Dr Reddy's Laboratories slipped up to 2 per cent at Rs 6,875.05 per share on the BSE in Monday's intraday trade

USFDA scrutiny delays generic drug approvals for major Indian pharma firms

Big Pharma companies Cipla, Sun Pharma, Aurobindo Pharma, Dr Reddy's, and Lupin face intense scrutiny from the US Food and Drug Administration (USFDA)

Sun Pharma receives US FDA approval for drug to treat alopecia areata

Autoimmune disorder characterised by hair loss affects some 700,000 people in the US

Sun Pharma hits all time high on US FDA nod for alopecia drug 'Leqselvi'

This came after Sun Pharmaceuticals announced that the US Food and Drug Administration (USFDA) has approved its new drug application for Deuruxolitinib, a new treatment for Alopecia Areata

Gland Pharma, Zydus Lifesciences secure USFDA approvals for key medications

Gland Pharma, a Hyderabad-based generic injectable-focused company, received tentative approval for Latanoprostene Bunod Ophthalmic Solution, 0.024 per cent