Page 6 - Usfda

Alembic Pharmaceuticals gets USFDA nod for hypertension treatment capsules

Alembic Pharmaceuticals Ltd on Monday said it has received final approval from the US health regulator for its generic Diltiazem Hydrochloride extended-release capsules indicated for the treatment of hypertension. The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) for Diltiazem Hydrochloride Extended-Release Capsules of strengths 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg, Alembic Pharmaceuticals Ltd (Alembic) said in a statement. These capsules are indicated for the treatment of hypertension. These capsules may be used alone or in combination with other antihypertensive medications. Moreover, Diltiazem Hydrochloride is also indicated for the management of chronic stable angina and angina due to coronary artery spasm, the company said. Diltiazem Hydrochloride extended-release capsules 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg have an estimated market size of USD 105.3 million for the 12 months ended June 2024, the company ...

McDonald's E coli case count rises as officials inspect onion grower

Federal officials have reported more cases of E. coli poisoning among people who ate at McDonald's, as government investigators seeking the outbreak's source identified an onion grower of interest in Washington state. The Food and Drug Administration said 90 people across 13 states have fallen ill in the outbreak, up from 75 at the end of last week. The number of people hospitalised increased by five, to 27 people. One death has been tied to the outbreak. Officials have said raw, slivered onions on McDonald's Quarter Pounder hamburgers are the likely source of the E. coli. McDonald's said the onions came from a single supplier, the California-based Taylor Farms. The company has since recalled the yellow onions it sent to McDonald's and other restaurant chains. The FDA said Wednesday it has begun inspecting Taylor Farm's processing centre in Colorado Springs as well as an onion grower of interest in Washington state. It did not name the grower. More than 80 per cent of people with E

Zydus Lifesciences gets USFDA nod for generic schizophrenia treatment drug

Zydus Lifesciences Ltd on Thursday said it has received final approval from the US health regulator to manufacture its generic version of Paliperidone extended-release tablets, used to treat schizophrenia. The approval by the US Food and Drug Administration (USFDA) is for Paliperidone extended-release tablets of strengths 1.5 mg, 3 mg, 6 mg, and 9 mg, Zydus Lifesciences said in a regulatory filing. These tablets will be produced at the group's manufacturing site at SEZ, Ahmedabad, it added. Paliperidone extended-release tablets are indicated for the acute and maintenance treatment of schizophrenia, acute treatment of schizoaffective disorder as monotherapy and acute treatment of schizoaffective disorder as an adjunct to mood stabilisers and/or antidepressants, the company said.

US FDA grants fast track status to Wockhardt's novel antibiotic WCK 6777

WCK 6777 is a once-a-day, β-lactam enhancer used for outpatient parenteral antimicrobial therapy

Eli Lilly's blockbuster weight-loss drug no longer in shortage in US: USFDA

The shortage of all doses of the drug, tirzepatide, sold as Mounjaro for diabetes and Zepbound for weight management has been resolved

Zydus Lifesciences receives USFDA approval to produce prostrate cancer drug

Zydus Lifesciences on Wednesday said it has received approval from the US health regulator to produce a generic prostate cancer treatment drug. The company has received tentative approval from the US Food and Drug Administration (USFDA) to manufacture Enzalutamide tablets (40 mg and 80 mg), the drug maker said in a regulatory filing. Enzalutamide tablets are androgen receptor inhibitors indicated for the treatment of patients with castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer. The product would be manufactured at the Group's manufacturing site at SEZ, Ahmedabad. As per IQVIA MAT July 2024 data, Enzalutamide tablets (40 mg and 80 mg) had annual sales of USD 1,417.2 million in the US. The Zydus group now has 400 approvals and has so far filed over 465 Abbreviated New Drug Application (ANDAs) since the commencement of the filing process in FY 2003-04, it said.

Aurobindo Pharma subsidiary gets 10 observations from USFDA for API plant

Aurobindo Pharma on Monday said the US health regulator has issued 10 observations after inspecting the API facility of its subsidiary in Telangana. The US Food and Drug Administration (USFDA) inspected Unit-II, an active pharmaceutical ingredients (API) manufacturing facility of Apitoria Pharma, a wholly-owned subsidiary of the company, in Sangareddy district from September 23-27, 2024, the Hyderabad-based drug maker said in a regulatory filing. The inspection closed with 10 observations, it added. The observations are procedural in nature and will be responded to within the stipulated time, the drug maker stated. Shares of Aurobindo Pharma on Monday ended 3.16 per cent down at Rs 1,462 apiece on BSE.

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