Page 2 - Usfda

Biocon gets USFDA's tentative approval for antibacterial drug Rifaximin

The USFDA's tentative approval means Biocon Pharma's Rifaximin 550 mg meets regulatory requirements but cannot be marketed in the US yet due to patents or exclusivity on the original drug

Wockhardt files new drug application with USFDA for antibacterial drug

Drug firm Wockhardt on Wednesday said it has submitted a new drug application for its novel antibacterial drug with the US health regulator. The company has submitted a New Drug Application (NDA) to the US Food and Drug Administration (USFDA) for its novel antibacterial agent Zidebactam-Cefepime injection, the Mumbai-based drugmaker said in a regulatory filing. The NDA seeks approval for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, with or without concurrent bacteremia caused by Gram-negative bacteria, including multidrug-resistant (MDR), it added. In the US and EU, more than 8 million cases of cUTI are reported every year, reflecting the global burden of Gram-negative infections, the drug firm stated. "This milestone marks the first-ever NDA submission to the US FDA for a drug, fully discovered and developed by an Indian pharmaceutical company, a momentous achievement for Indian innovation," Wockhardt Ltd said. The NDA submission follows

Trump to launch 'TrumpRx', to make drugs cheaper for Americans, says report

After talks with US President Donald Trump, global pharma giant Pfizer is further expected to announce a $70 billion investment in research, development and domestic manufacturing

Glenmark, Zydus recall products in US over manufacturing issues: USFDA

Domestic drugmakers Glenmark, Granules India, Sun Pharma, Zydus and Unichem are recalling products in the US market for various manufacturing issues, according to the US Food and Drug Administration (USFDA). The drugmakers are voluntarily recalling affected lots in the American market, the US health regulator said in its latest Enforcement Report. A US-based subsidiary of the Mumbai-based Glenmark Pharmaceuticals is recalling 13,824 Azelaic Acid Gel tubes produced at the company's Goa plant due to "CGMP deviations" following market complaints received for gritty texture, USFDA said. New Jersey-based Glenmark Pharmaceuticals Inc, USA, initiated the Class II nationwide recall on September 17. As per the USFDA, a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal. Hyderabad-based Granules India is recalling over 49,000

USFDA cautions doctors on acetaminophen use in pregnancy, cites risks

The US drug regulator flagged concerns over acetaminophen use in pregnancy, citing studies linking it to autism and ADHD, while noting no proven causal relationship

Indian pharma faces US revenue slowdown amid scrutiny, tariffs: ICRA

ICRA projects Indian pharma firms' US revenue growth to slow due to price erosion, USFDA scrutiny and tariff risks, while high dependence on Chinese APIs persists despite PLI

Natco Pharma surges 5% after USFDA classifies Hyderabad facility as VAI

Natco Pharma stock was trading at ₹884.5, up 3.2 per cent compared to the previous session's close of ₹857.25 on the NSE

Biocon Biologics secures USFDA approval for Bosaya and Aukelso biosimilars

Biocon Biologics gets USFDA approval for Bosaya and Aukelso, denosumab biosimilars of Prolia and Xgeva, with provisional interchangeability status to widen patient access

Pharma in bitter health: Stocks sink upto 38% in 2025; time to bottom fish?

Among stocks, Natco Pharma plunged 37.85%, Ipca Labs 22.43%, Aurobindo Pharma 17.99%, and Sun Pharma 14.30%. Other laggards include Lupin (13.25%), and Dr Reddy's (5.17%).

Caplin Point's unit gets USFDA nod for generic milrinone lactate injection

Pharma firm Caplin Point Laboratories Ltd on Wednesday said its arm Caplin Steriles Ltd has received final approval from the US health regulator for its generic milrinone lactate in 5 per cent dextrose injection indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) milrinone lactate in 5 per cent Dextrose Injection of strengths 20 mg/100 mL and 40 mg/200 mL in single-dose infusion bags, Caplin Point Laboratories said in a regulatory filing. The approved injection is a generic therapeutic equivalent version of the reference listed drug PRIMACOR in dextrose 5 per cent, by Sanofi Aventis US LLC, it added. Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure, the company said. Citing IQVIA (IMS Health) data, the company said milrinone lactate in 5 per cent ...

Lupin share price rises 3% as USFDA okays schizophrenia drug; details

Drugmaker Lupin said it has received the USFDA's approval for Risperidone for extended-release injectable suspension

Sun Pharma slips 5% in 2 days, nears 52-wk low; why drug stock trades weak?

Thus far in August 2025, Sun Pharma has underperformed the market by falling 8 per cent, as compared to a 1 per cent decline in the BSE Sensex

US pharma tariffs unlikely to hit Indian drugmakers materially: Ind-Ra

Ind-Ra said US tariffs may cause only short-term pricing impact for Indian pharma as firms remain fortified by diversification, strong balance sheets, and global market positioning

Albertsons looks to make in India for the global market: Sunil Gopinath

Gopinath talks about his strategies and priorities as Albertsons plans to hire about 1,000 employees in the next 18 months and what will fuel the next phase of GCC growth in the country

Alembic gets USFDA's approval for generic acne drug Tretinoin Cream

Alembic Pharmaceuticals on Monday said it has received approval from the US health regulator to market a generic medication to treat acne vulgaris in the US market. The company has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Tretinoin Cream USP (0.025 per cent), the drug maker said in a statement. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Retin-A Cream, 0.025 pr cent, of Bausch Health US, LLC, it added. Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. According to IQVIA, Tretinoin cream USP, 0.025 per cent, has an estimated market size of USD 94 million for the twelve months ending June 2025. Shares of the company were trading 1.03 per cent up at Rs 968.10 apiece on BSE.

Poly Medicure to invest ₹500 cr in new plants for global market push

Poly Medicure to set up three plants in Faridabad, Haridwar, and Jaipur for dialysis, cardiology, and oncology devices, targeting US, Europe, and Brazil markets by FY28

Zydus gets USFDA approval for a high blood pressure to treat angina

Zydus Lifesciences on Monday said it has received approval from the US health regulator to market a drug used to treat angina and high blood pressure. The company has received final approval from the US Food and Drug Administration (USFDA) for Diltiazem Hydrochloride tablets in strengths of 30 mg, 60 mg, 90 mg, and 120 mg, the drug maker said in a statement. Diltiazem Hydrochloride Tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm. It belongs to a class of drugs called calcium-channel blockers. Diltiazem works by relaxing blood vessels, which reduces the workload on the heart and increases blood and oxygen supply to the heart muscle. The company said Diltiazem Hydrochloride Tablets will be produced at Zydus Lifesciences' Baddi plant in Himachal Pradesh. As per IQVIA MAT June 2025 data, Diltiazem Hydrochloride Tablets had annual sales of USD 13.9 million in the US.

Zydus Lifesciences up 2% after USFDA nods Diltiazem Hydrochloride tablets

Zydus Lifesciences share price rose 2 per cent, logging an intra-day high at ₹955 per share on BSE after USFDA gave its approval for Diltiazem Hydrochloride Tablets.

India launches formal rules to fix, streamline drug and device clearances

India has issued first official guidelines for expert panels to bring consistency, speed, and transparency to drug and device approvals amid a broader regulatory overhaul

Sun Pharma, Lupin, Dr Reddy's recall products in US due to mfg issues

Domestic drug majors Sun Pharma, Lupin and Dr Reddy's Laboratories are recalling drugs in the US market due to manufacturing issues and product mix up, according to the US health regulator. As per the latest Enforcement Report of US Food and Drug Administration (USFDA), the Mumbai-headquartered Sun Pharmaceutical Industries is recalling 5,448 bottles of a generic medication in the US. Princeton-based Sun Pharmaceutical Industries Inc is recalling the affected lot of Lisdexamfetamine Dimesylate capsules (60 mg) due to "Failed Dissolution Specifications", the US health regulator stated. The medication is used to treat attention deficit hyperactivity disorder (ADHD). The drug firm initiated the Class II recall in the US on June 16 this year, it added. Another Mumbai-based drug maker Lupin is recalling 58,968 bottles of a generic combination medication used to treat high blood pressure. Naples-based Lupin Pharmaceuticals Inc is recalling Lisinopril and Hydrochlorothiazide tablets (US