Page 13 - Usfda

USFDA puts on hold Sun Pharma trials on dermatological drug regimen

The US health regulator has directed Sun Pharma to stop trials of a dermatological drug with a 12 mg dose regimen as its usage could lead to blood clots. The drug major on Tuesday said it had a teleconference call with the US Food and Drug Administration (USFDA) regarding a pulmonary embolism (serious adverse events) occurring at the 12 mg dose in one of the long-term Open Label Extension (OLE) studies. As a result, the agency has placed the investigational new drug (IND) on partial clinical hold due to the potential for thrombotic events and is requiring that subjects currently on the 12 mg dose in the OLE studies discontinue that dose, it added. There have been no thrombotic events reported to date for the 8 mg dose and USFDA has not placed the 8 mg dose on hold, the drugmaker said in a regulatory filing. "We are taking immediate steps to transition the patients in the OLE studies to the 8 mg BID dose arm in the ongoing studies," Sun Pharmaceutical Industries stated. No ...

USFDA puts partial clinical hold on Sun Pharma's dermatological drug

USFDA put a partial clinical hold on its application for an experimental dermatological drug due to the potential of thrombotic events

Pharma firm Ipca Labs' plant gets 3 observations from US drugs regulator

The observations were followed by the USFDA inspection at the site from April 18 to April 26

Zydus Lifesciences gets nod from USFDA for metronidazole topical cream

The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad

Zydus Lifesciences gets USFDA nod to its generic medicine for high BP

Zydus Lifesciences Ltd on Thursday said it has received final approval from the US health regulator to manufacture and market its generic version of metoprolol tartrate tablets used to treat high blood pressure. The approval granted by the United States Food and Drug Administration (USFDA) is for metoprolol tartrate tablets of strengths 25 mg, 50 mg, and 100 mg, Zydus Lifesciences said in a regulatory filing. The drug will be manufactured at the group's formulation manufacturing facility at Baddi in Himachal Pradesh, it added. Metoprolol is used with or without other medications to treat high blood pressure (hypertension), the company said, adding the medication is also used to treat chest pain (angina) and to improve survival after a heart attack. Metoprolol tartrate tablets 25 mg, 50 mg, and 100 mg had annual sales of USD 45.2 million in the US, the company said citing IQVIA MAT February 2023 data.

Zydus Lifesciences gets USFDA nod for generic female hormone in US market

Zydus Lifesciences on Tuesday said it has received approval from the US regulator to market a generic female hormone, which helps reduce symptoms of menopause, in the US market. The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Estradiol Transdermal System USP in the American market. Estradiol transdermal system is indicated for prevention of postmenopausal osteoporosis. The company said the drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad in Gujarat. As per the IQVIA sales data, Estradiol Transdermal System had annual sales of USD 1.9 million in the US.

Global Pharma recalls 50,000 tubes of contaminated eye drops in US: USFDA

Global Pharma Healthcare is recalling 50,000 tubes of eye drops in the US market due to bacterial contamination, according to the US Food and Drug Administration (USFDA). As per its latest Enforcement Report, the US health regulator noted that the Chennai-based drug firm is recalling the affected lot of eye lubricant for artificial tears which have been linked to vision loss in the US. The lot has been manufactured by Chennai-based Global Pharma Healthcare and distributed in the US market by New York-based Delsam Pharma, the USFDA said. Stating the reason for recall, the US health regulator said: "FDA analysis found unopened tubes to be contaminated with bacteria." The company initiated the Class I recall on February 24 this year. As per the USFDA, a Class I recall is the most urgent of the three types of FDA recalls and usually pertains to defective products that can cause serious health problems. In February, Global Pharma Healthcare had announced that it is recalling its entir

USFDA issues Form-483 with 10 observations to Lupin's Pithampur plant

Drug firm Lupin on Thursday said the US health regulator has issued a Form-483 with ten observations after inspecting its Pithampur Unit-2 manufacturing facility. The US Food and Drug Administration (USFDA) inspected the plant from March 21 to March 29, 2023. The inspection closed with issuance of a Form-483 with ten observations, Lupin said in a regulatory filing. "We are addressing the observations comprehensively and will work with the US FDA to resolve these issues at the earliest," it added. 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 in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. In November last year, USFDA had issued Form-483 with eight observations each for product and raw material production centres at Lupin's Mandideep-based manufacturing facility. In October 2022, the drugmaker announced that the US health .

Lupin gets tentative USFDA approval to market generic valbenazine capsules

Pharmaceuticals firm Lupin Ltd on Monday said it has received tentative approval from the US health regulator to market its generic valbenazine capsules used to treat involuntary movements of the face, tongue or other body parts. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of valbenazine capsules of strengths 40 mg, 60 mg and 80 mg, the company said in a regulatory filing. These are the generic equivalent of Ingrezza capsules, 40 mg, 60 mg, and 80 mg, of Neurocrine Biosciences, Inc, it added. Valbenazine capsules had estimated annual sales of USD 1,235 million in the US, the company said, citing IQVIA MAT December 2022 data.

Zydus Lifesciences gets US health regulator's nod for its generic medicine

Zydus Lifesciences Ltd on Friday said it has received final approval from the US health regulator for its generic doxepin hydrochloride capsules used in the treatment of depression and anxiety. The approval granted by the US Food and Drug Administration (USFDA) is for doxepin hydrochloride capsules of strength 150 mg, the company said in a regulatory filing. The drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad, it added. Doxepin hydrochloride capsule is indicated to treat mental/mood problems such as depression and anxiety. It helps improve moods and feelings of well-being, relieves anxiety and tension, helps sleep better and increases the energy level, it added. The drug had annual sales of USD 2.11 million in the US, the company said citing IQVIA MAT January 2023 data.

Glenmark gets USFDA nod for generic drug with 180-day exclusivity

Glenmark Pharmaceuticals on Thursday said it has received an approval from the US health regulator to market a generic medication to treat plaque psoriasis. The company has received final approval from the US Food & Drug Administration (USFDA) for Calcipotriene and Betamethasone Dipropionate Foam, the generic version of Leo Pharma's Enstilar, Glenmark Pharma said in a statement. The USFDA noted that the Mumbai-based drug firm was the first abbreviated new drug application (ANDA) applicant with a paragraph IV certification for Calcipotriene and Betamethasone Dipropionate Foam, it added. "Therefore, with this approval, Glenmark is eligible for 180 days of generic drug exclusivity for Calcipotriene and Betamethasone Dipropionate Foam," the drug firm said. According to IQVIA sales data for the 12-month period ended January 2023, Enstilar Foam (0.005 per cent/0.064 per cent) achieved annual sales of around USD 93.6 million. Shares of the company were trading 0.49 per cent down at Rs ..

Glenmark gets USFDA nod to market generic medication to treat schizophrenia

Glenmark Pharmaceuticals on Monday said it has received approval from the US health regulator to market a generic product used to treat schizophrenia and in some cases to control severe nausea. The company has received nod from the US Food & Drug Administration (USFDA) for Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg, the Mumbai-based drug maker said in a statement. The company's product is the generic version of GlaxoSmithKline's Compazine tablets, it added. According to IQVIA sales data for the 12-month period ending January 2023, the Compazine tablets 5 mg and 10 mg achieved annual sales of around USD 26.9 million. Glenmark said its current portfolio consists of 182 products authorised for distribution in the US marketplace and 46 ANDAs (Abbreviated New Drug Applications) pending approval with the USFDA. PTI MSS.

Glenmark Pharma get USFDA nod for human trial of cancer-treating drug

Glenmark Pharmaceuticals on Thursday said its arm has received acceptance from the US health regulator to proceed with a phase 1/2, first-in-human trial for its investigational new drug aimed for treatment of patients with advanced cancers. In a regulatory filing, the company said Glenmark Specialty SA received the acceptance from the US Food and Drug Administration (USFDA) for the investigational new drug (IND) application 'GRC 54276' for the treatment of patients with advanced solid tumours and lymphomas. Developed by Glenmark, GRC 54276 is an orally available, small molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor. HPK1-regulated functions are involved in nearly every step of the cancer-immunity cycle, making it an attractive target for immuno-oncology, the company said. By inhibiting HPK1, GRC 54276 is designed to potentially enhance the patient's own immune system to fight cancers, it added. "Now that the (US)FDA has accepted our IND application, we look forward to

Glenmark Pharma receives USFDA approval for generic antibiotic drug

Glenmark Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market a generic antibiotic drug. The company has received final approval from the US Food & Drug Administration (USFDA) for Clindamycin Hydrochloride Capsules, a generic version of Pfizer's Cleocin capsules, Glenmark Pharma said in a statement. Glenmark's Clindamycin Hydrochloride Capsules in strengths of 75 mg, 150 mg, and 300 mg, will be distributed in the US by Glenmark Pharmaceuticals Inc, it added. According to IQVIA sales data for the 12-month period ending January 2023, the Cleocin Hydrochloride Capsules, 75 mg, 150 mg, and 300 mg achieved annual sales of around USD 33.6 million. Glenmark shares were trading 0.12 per cent up at Rs 426.10 apiece on the BSE.

Marksans Pharma gets USFDA nod for generic version of Famotidine tablets

Marksans Pharma Ltd on Friday said it has received final approval from the US health regulator for its generic version of Famotidine tablets indicated for the treatment of acid indigestion and heartburn. The approval granted by the US Food & Drugs Administration (USFDA) for the abbreviated new drug application (ANDA) of Famotidine tablets is for strengths of 10 mg and 20 mg for over-the-counter (OTC) use, Marksans Pharma said in a regulatory filing. The product is bioequivalent to the reference-listed drug (RLD), Pepcid AC tablets, a registered trademark of Johnson & Johnson Consumer Inc which has sales of over USD 200 million in the US market, it added. "We are delighted to continue OTC gastro portfolio expansion for our customers and it will help us to fulfill an important therapy gap created in the Antacids market due to Ranitidine withdrawal," Marksans Pharma Managing Director Mark Saldanha said. The company's OTC Famotidine tablets are acid reducers, used to treat ...

Alembic Pharma gets USFDA nod to market generic antidepressant drug

Alembic Pharmaceuticals on Thursday said it has received an approval from the US health regulator to market a generic antidepressant medication in the American market. The company has received an approval from the US Food & Drug Administration to market Brexpiprazole tablets in strengths of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg, the drug firm said in a statement. The company's product is therapeutically equivalent to Otsuka Pharmaceutical Co's reference listed drug product Rexulti tablets, it added. Brexpiprazole tablets are indicated as an adjunctive therapy to antidepressants for the treatment of major depressive disorder and for the treatment of schizophrenia. According to IQVIA data, Brexpiprazole tablets in strenghts of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg have an estimated market size of USD 1.6 billion for 12 months ended December 2022. The US market is the world's largest for pharmaceutical products. In 2021-22 fiscal, India's total pharma exports to global ...

Alembic Pharma gets USFDA approval to market generic cancer drug

Alembic Pharmaceuticals on Wednesday said it has received approval from the US health regulator to market a generic breast cancer drug. The company has received approval from the US Food & Drug Administration (USFDA) to market Docetaxel Injection in multiple dose vials, the drug maker said in a statement. The company's approved product is therapeutically equivalent to Hospira Inc's drug. Docetaxel Injections are indicated for breast cancer, non-small cell lung cancer, castration-resistant prostate cancer, gastric adenocarcinoma and squamous cell carcinoma of head and neck. According to IQVIA data, Docetaxel injection has an estimated market size of USD 11 million in the US market. Shares of the company were trading 0.72 per cent down at Rs 506.40 apiece on the BSE.

Zydus Lifesciences receives USFDA approval to market generic drug

Zydus Lifesciences on Tuesday said it has received approval from the US health regulator to market a generic medication to prevent and treat blood clots. The company has received approval from the US Food and Drug Administration (USFDA) to market Apixaban tablets in strengths of 2.5 and 5 mg, according to a regulatory filing. Apixaban blocks the activity of certain clotting substances in the blood. It is used to lower the risk of stroke or a blood clot in people with a heart rhythm disorder called atrial fibrillation. It is also used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery. The drug will be manufactured at the Zydus group's formulation manufacturing facility at Moraiya, Ahmedabad. As per IQVIA MAT December 2022 data, Apixaban tablets had annual sales of USD 18,876 million in the US.

Granules gets USFDA nod to market generic medicine for high blood pressure

Drug firm Granules India on Monday said it has received approval from the US health regulator to market a generic product to treat high blood pressure. The company has received approval from the US Food & Drug Administration (USFDA) to market Losartan Potassium tablets in strengths of 25 mg, 50 mg, and 100 mg, Granules India said in a regulatory filing. The Hyderabad-based company's product is bioequivalent to the Organon LLC's Cozaar tablets. According to IQVIA/IMS Health, the current annual US market for Losartan potassium tablets is around USD 336 million. Shares of the company were trading 1.24 per cent down at Rs 281.75 apiece on the BSE.

Nifty Pharma dips to 7-mth low; bears may gain control if breaks 52-wk low

Barring Sun Pharmaceutical Industries, which is anticipated to rally up to 10 per cent; other stocks indicate weak bias, as per technical charts