Iqvia Financial News

Alembic Pharmaceuticals Limited on Monday announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe.

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.

Paliperidone extended-release tablets indicated for the treatment of schizophrenia. The approval by the US Food & Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) Paliperidone extended-release tablets of strengths 1.5 mg, 3 mg, 6 mg, and 9 mg, Alembic Pharmaceuticals said in a regulatory filing. The approved ANDA is therapeutically equivalent to the Reference Listed Drug product (RLD), Invega extended-release tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg, of Janssen Pharmaceuticals, Inc, it added. Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for the treatment of schizophrenia and it is also indicated for the treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilisers and/or antidepressants.

Alembic Pharmaceuticals on Thursday said it has received tentative approval from the US health regulator for its generic Ivosidenib tablets used in the treatment of certain types of cancer of bone marrow and bile duct. The tentative approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Ivosidenib tablets of strength 250 mg, the company said in a regulatory filing. The approved ANDA is therapeutically equivalent to the reference listed drug product Tibsovo tablets, 250 mg, of Servier Pharmaceuticals LLC (Servier), it added. The company said Ivosidenib tablets are indicated for patients with newly diagnosed Acute Myeloid Leukemia (AML) as monotherapy in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.

US health regulator for its generic Dabigatran Etexilate capsules 75 mg and 150 mg used to reduce risk of stroke and blood clots in adults with a certain medical condition. The US Food & Drug Administration (USFDA) has also granted tentative approval for the Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate capsules 110 mg, Alembic Pharmaceuticals, said in a statement. The approved ANDA is therapeutically equivalent to the Reference Listed Drug product (RLD), Pradaxa Capsules, 75 mg, 110 mg, and 150 mg of Boehringer Ingelheim Pharmaceuticals, Inc. (Boehringer), it added. The Dabigatran Etexilate capsules are indicated for the reduction of risk of stroke and systemic embolism in adults who have a medical condition called atrial fibrillation that is not caused by a heart valve problem.

Dr Reddy's Laboratories Ltd on Wednesday said it has signed a licensing pact with US-based Ingenus Pharmaceuticals, LLC, to commercialise Cyclophosphamide injection used in treatment of cancer. The company's wholly-owned subsidiary Dr Reddy's Laboratories Inc and Ingenus Pharmaceuticals, LLC have entered into license agreement, Dr Reddy's Laboratories Ltd (DRL) said in a regulatory filing.

Cipla on Wednesday said it has received approval from the US health regulator to market a generic medication used to treat acromegaly and other conditions. The company has received the final approval from the US Food and Drug Administration (USFDA) to market Lanreotide injection in multiple strengths, the Mumbai-based drug maker said in a statement. The company's Lanreotide Injection is therapeutic equivalent generic version of Somatuline Depot Injection, it added. The drugmaker said its product is indicated for the treatment of patients with acromegaly and gastroenteropancreatic neuroendocrine tumours.

Zydus Lifesciences on Monday said it has launched a generic medication to treat overactive bladder in the US market. The company has launched Mirabegron extended-release tablets in strength of 25 mg in the US market after having received final approval from the US Food and Drug Administration (USFDA), Zydus Lifesciences said in a regulatory filing. Zydus is among the first suppliers to launch the generic version of Mirabegron extended-release tablets (USP 25 mg) in the US market. The company is also preparing to launch the 50 mg tablets in the market, it added.

Lupin on Monday said it has received approval from the US health regulator to market a generic medication to treat involuntary movements caused by tardive dyskinesia. The company has received approval from the US Food and Drug Administration (USFDA) to market Valbenazine Capsules in strength of 40 mg and 80 mg, the Mumbai-based drug firm said in a statement. The company's product is a generic equivalent of Neurocrine Biosciences, Inc's Ingrezza Capsules, it added. Lupin is one of the first abbreviated new drug application (ANDA) applicants and is eligible for 180 days of shared generic exclusivity, the company said.

₹426 crore ($51 million) as per IQVIA MAT February 2024. Sanofi said it will continue to own, manufacture and import them to the country. M.V.

condom category seems to have spiced up its growth rate, which nearly doubled in 2023. The Rs 1,755 crore segment grew to a five-year high last year at 13% by value compared with 7% in 2022, according to the latest IQVIA consumer health retail audit data sourced from executives. Companies said the segment is shifting away from being used for just protection to enhancing the experience. “Condoms were always sold from a safety perspective and youth felt the product was a hindrance for pleasure,” said Rajeev Juneja, managing director and vice chairman of Mankind Pharma, the maker of Manforce condoms, which has a 30.1% share. “So innovations have really helped attract younger consumers to the category. Also, women too now decide on the variants, unlike the historical trend of men being the sole decision makers.”

Millions of Americans who have used new obesity drugs like Wegovy to lose weight and improve health are wondering what happens if they stop taking them

Edelweiss Alternatives, the alternative asset arm of the Edelweiss Group, has finalised a deal to acquire MFAR Developers’ 1.21-million-sq-ft information technology park in Bengaluru for over Rs 1,475 crore, said multiple persons with direct knowledge of the development. This is the largest and first transaction for a complete buyout of an office tower so far this year. Edelweiss Alternatives is buying this asset through its rental fund, which is currently in the process of raising Rs 5,000 crore. The 12-storey office tower, which is in north Bengaluru’s Hebbal locality along Bellary Road and Outer Ring Road (ORR), is an independent asset within an ecosystem of large integrated mixed-use development.

Lupin announced on Sunday, January 14, that it has received approval from the US health regulator to market a generic drug to treat migraine and hypertension. The Mumbai-based company has received the nod from the US Food and Drug Administration (USFDA) for Propranolol Hydrochloride extended-release capsules in multiple strengths, said Lupin Ltd in a regulatory filing to the stock exchanges today. The company's product is the generic version of ANI Pharmaceuticals' Inderal LA extended-release capsules, it added.

By GursimranKaur Mehar and Mrinmay Dey

Zydus Lifesciences Ltd on Friday said it has received final approval from the US health regulator for its generic version of Ivabradine tablets indicated for the treatment of heart failure. The approval by the US Food and Drug Administration (USFDA) is for Ivabradine tablets of strengths 5 mg and 7.5 mg, the company said in a regulatory filing.

Alembic Pharma on Tuesday reported a Rs 137 crore net profit in Q2FY24, which is a 3% year-on-year (YoY) increase compared to the corresponding period of the previous year. The company reported Rs 133 crore in net profit in Q2FY23. Revenues grew 8% to Rs.1595 crore in Q2FY24 compared to Rs 1475 crore last year. The earnings before interest, tax, depreciation and amortization (EBITA) declined 6% YoY to Rs 218 crore.

₹151 crore, led by healthy growth in domestic and international business. Revenue increased 9% YoY to ₹882 crore in the fiscal second quarter (Q2FY24). Earnings before interest, tax, depreciation, and amortization (Ebitda) for the quarter stood at ₹251 crore, a 24% improvement YoY, with an Ebitda margin of 28.5%., the company said in a notification to the exchanges.

₹1,128.40 apiece on the BSE. Also Read: Lupin Q2 Results: Board to meet on November 8 to discuss unaudited results This month, the pharma major received approval from the US FDA to market its generic Fluconazole tablets and another generic medicine used to treat daytime sleeplessness. Fluconazole tablets are used in the treatment of fungal infections.

By Michael Erman

₹1,144.90, against previous close of ₹1,168. Check our Markets LIVE coverage here On October 23, Lupin said it has received approval from the United States Food and Drug Adminstration (US FDA) to market its generic Fluconazole tablets used in the treatment of fungal infections, the company told the exchanges.