Page 14 - Usfda

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

Cipla shares fall over 6% after its unit gets 8 observations from USFDA

Shares of Cipla on Monday ended over 6 per cent lower after the company received 'Form 483' with eight observations for its Pithampur-based manufacturing facility. The stock declined 6.02 per cent to settle at Rs 964.05 apiece on the BSE. During the day, it tumbled 6.78 per cent to Rs 956.20. On the NSE, it tanked 6.11 per cent to end at Rs 963 per share. In volume terms, 2.38 lakh shares were traded on the BSE and over 58.29 lakh shares on the NSE during the day. The US Food and Drug Administration (USFDA) conducted a current Good Manufacturing Practices (cGMP) inspection at the manufacturing facility from February 6-17, the Mumbai-based drug firm said in a regulatory filing on Saturday. On conclusion of the inspection, the company has received eight inspectional observations in Form 483, it added. The company will work closely with the USFDA and is committed to address these comprehensively within stipulated time, it said. As per USFDA, Form 483 is issued to a firm's managemen

Drug firm Glenmark gets USFDA nod for generic diabetes drug to market in US

Drug firm Glenmark said it has received approval from the US health regulator to market a generic medication to treat diabetes in the American market. Glenmark Pharmaceuticals Inc, USA, a unit of the company, has received tentative approval from the US Food & Drug Administration (US FDA) for Saxagliptin Tablets in strengths of 2.5 mg and 5 mg, the Mumbai-based drug maker said in a statement. The company's product is the generic version of AstraZeneca AB's Onglyza tablets (2.5 mg and 5 mg), it added. According to IQVIA sales data for the 12-month period ending December 2022, the Onglyza tablets (2.5 mg and 5 mg) achieved annual sales of around USD 122.3 million. Glenmark said its current portfolio consists of 179 products authorised for distribution in the US marketplace. The drug firm has 46 abbreviated new drug applications (ANDAs) pending approval with the USFDA, it added. In addition to these internal filings, Glenmark continues to identify and explore external development ...

Natco Pharma jumps 4% on filing generic version of oncology drug in US

The drug major filed an abbreviated new drug application (ANDA) for generic versions of Olaparib tablets - 100 mg and 150 mg with the US Food and Drug Administration (USFDA)

Sun Pharma gets US health regulator nod to market generic medication

Sun Pharmaceutical Industries on Friday said its subsidiary has received approval from the US health regulator to market a generic medication used in the treatment of multiple myeloma. The company has received final approval from the US Food and Drug Administration (USFDA) for the generic lenalidomide capsules in multiple strengths, Sun Pharma said in a statement. In June 2021, Sun Pharma entered into a settlement with Celgene Corporation (Celgene) to resolve the patent litigation regarding its generic lenalidomide capsules. Under the terms of this settlement, Celgene granted Sun Pharma a license to patents required to manufacture and sell certain limited quantities of generic lenalidomide capsules in the US, beginning sometime after March 2022. In addition, the license allows Sun Pharma to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the US beginning January 31, 2026. Shares of Sun Pharma were trading 0.48 per cent down at Rs 1,002 apiece on the

Lupin bags gets approval from USFDA to market generic product in America

Drug maker Lupin on Thursday said it has received approval from the US health regulator to market a generic medication, used before a surgery to decrease the volume of secretions from mouth, lungs and stomach, in the American market. The company has received approval from the US Food and Drug Administration (USFDA) for Glycopyrrolate Injection, a generic equivalent of Hikma Pharmaceuticals' Robinul Injection, the Mumbai-based drug maker said in a statement. The product marks the first approval from the company's new injectable facility in Nagpur, it added. "We are committed to building a strong injectable business as part of our growth strategy," Lupin CEO Vinita Gupta said. With the approval of the product from the Nagpur facility, the company can now fast-track its injectable portfolio rollout and build on R&D capabilities in complex products, she added. The approval for Glycopyrrolate clears the path for more internally manufactured injectable products, Gupta stated. As per ..

Regulators halt eye products' production at Global Pharma Healthcare site

Firm under US FDA scanner for bacterial contamination of its eye drops

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Alembic Pharmaceuticals gets USFDA nod to market generic cancer drug

The company's product is therapeutically equivalent to AstraZeneca UK's Calquence Capsules (100 mg)

Zydus gets USFDA nod to market generic medicine for treating depression

Levomilnacipran is a serotonin and norepinephrine reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) in adults

USFDA pulls up Sun Pharma for manufacturing lapses in Halol plant

The US health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products, at its Gujarat-based plant. In a warning letter, the US Food and Drug Administration (USFDA) pointed out various lapses at the Halol plant which produces finished pharmaceutical products. "This warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals... Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated," the USFDA stated. The health regulator inspected the manufacturing facility from April 26 to May 9, 2022. A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. In the letter to Mumbai-based company, the USFDA pointed out

Lupin gets US FDA nod for generic medicine to treat heart ailments

Pharmaceuticals firm Lupin Ltd on Tuesday said it has received approval from the US health regulator for its generic version of Prasugrel tablets. The medicine is indicated to prevent other serious heart and blood vessel problems in patients with recent heart attacks, strokes and blood clots in stents. The approval by the US Food and Drug Administration (US FDA) for the Abbreviated New Drug Application (ANDA) of Prasugrel tablets of strengths 5 mg and 10 mg, the company said in a regulatory filing. These are the generic equivalent of Effient tablets, 5 mg and 10 mg of Cosette Pharmaceuticals, Inc. "The product will be manufactured at Lupin's facility in Goa, India," it added. Prasugrel Tablets 5 mg and 10 mg had estimated annual sales of USD 18 million in the US, Lupin said citing IQVIA MAT September 2022 data.

Zydus Life gets final nod from USFDA for generic version of insomnia drug

Zydus Lifesciences Ltd on Friday said it has received final approval from the US health regulator to market its generic version of Triazolam tablets used on a short-term basis to treat insomnia. The approval granted by the US Food and Drug Administration (USFDA) is to market Triazolam tablets of strengths 0.125 mg and 0.25 mg, the company said in a regulatory filing. The medicine is used on a short-term basis to treat insomnia -- difficulty falling asleep or staying asleep. It works by slowing activity in the brain to allow sleep. It will be manufactured at the group's formulation manufacturing facility at Moraiya, Ahmedabad, the company said. Triazolam tablets had annual sales of USD 11.7 million in the US, the company said, citing IQVIA MAT September 2022 data.

Alembic Pharma gets USFDA nod for generic drug to treat breast cancer

Alembic Pharmaceuticals on Monday said it has received final approval from the US health regulator for its generic Fulvestrant injection used in treatment of breast cancer. The approval granted by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA), Fulvestrant injection of strength 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe, the company said in a statement. The approved injection is therapeutically equivalent to the reference listed drug product (RLD), Faslodex Injection, of AstraZeneca Pharmaceuticals LP, it added. Fulvestrant injection is an estrogen receptor antagonist indicated for the treatment of breast cancer, the company said. For 12 months ended September 2022, Fulvestrant injection, 250 mg/5 mL, had an estimated market size of USD 71 million, the company said citing IQVIA data.