Generic Drugs

Zydus recalls over 55k bottles of generic drug used to treat gout in US

Drug firm Zydus Lifesciences is recalling over 55,000 bottles of generic medication in the US market due to failed impurities specifications. As per the latest enforcement report by the US Food and Drug Administration (USFDA), Zydus Pharmaceuticals (USA) Inc is recalling 21,936 (30 count) and 33,096 (100 count) bottles of Colchicine tablets, which are used to treat gout. The affected lot is manufactured by Ahmedabad-based Zydus Lifesciences and marketed in the US by New Jersey-based Zydus Pharmaceuticals (USA) Inc. USFDA said the company is recalling the product due to "failed impurities/ degradation specifications". An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine, it added. Zydus commenced the Class III recall on February 24 this year. As per the USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health ...

Issued show cause notice to 31 firms for online sale of drugs: Govt in LS

The CDSCO has issued show cause notices to 31 firms based on representations raising concerns over the sale of drugs online or through other electronic platforms in contravention to the provisions of the Drugs and Cosmetics Act, 1940, the government informed the Lok Sabha on Friday. Cases concerning the quality of drugs, when reported, was is taken up with the State Licensing Authority (SLA) concerned for necessary action under the provisions of the Drugs and Cosmetics Act, Minister of State for Health Bharati Pravin Pawar said in a written reply. The SLAs are empowered to take action on violation of any conditions of such licenses, including prosecution in an appropriate court of law. She also told the Lower House of Parliament that as informed by Central Drugs Standard Control Organisation (CDSCO), various representations are received raising concerns regarding the sale of drugs through online or other electronic platforms in contravention to the provisions of the Drugs and ...

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.

On the agenda: Budget focuses on quality and reach of healthcare in India

It is hoped there is both a short- and long-term vision to make India a leader in the pharmaceutical sector beyond generic drug manufacture

Suven starts Phase 3 trial for first home-grown Alzheimer's drug

Clinical trial randomisation is the process of assigning patients by chance to groups that receive different treatments

Biocon Q2 results: Net profit declines 10% to Rs 168 crore, revenue up 26%

Biocon's core Ebitda came in at Rs 816 crore, up 34 per cent

Zydus Lifesciences gets USFDA nod for generic Valbenazine, Roflumilast

Zydus Lifesciences on Monday said it has got tentative approval from the US health regulator to market its generic versions of Valbenazine capsules and Roflumilast tablets. Valbenazine capsules are indicated for the treatment of tardive dyskinesia (uncontrolled movement of body parts such as face and tongue) while Roflumilast tablets are used for reducing risk of chronic obstructive pulmonary disease in severely affected patients associated with chronic bronchitis and a history of exacerbations. The tentative approval granted by the US Food and Drug Administration (USFDA) to the company's arm Zydus Worldwide DMCC to market Valbenazine capsules is for strengths 40 mg, 60 mg, and 80 mg, Zydus Lifesciences said in a regulatory filing. As per IQVIA MAT August 2022 data, Valbenazine capsules had annual sales of USD 781 million in the US. Zydus further said its US subsidiary Zydus Pharmaceuticals (USA) Inc has also received tentative approval from the USFDA to market Roflumilast tablets

Centre defends Universal Code of Pharma Marketing Practices in apex court

The government further added that it is working on providing statutory backing to the UCPMP code and "it is a time-consuming process, which cannot be completed in haste"

Zydus Lifesciences' generic drug for overactive bladder gets USFDA nod

Zydus Lifesciences on Monday said it has received the USFDA's final nod to market its generic version of Mirabegron extended-release tablets used to treat overactive bladder, with 180 days of shared generic drug exclusivity. The final approval granted by the US Food and Drug Administration (USFDA) to the company's US arm Zydus Pharmaceuticals Inc is for the tablets of strengths 25 mg and 50 mg, it said in a regulatory filing. Zydus was one of the first applicants to submit a substantially complete ANDA (abbreviated new drugs application) with a paragraph IV certification for Mirabegron extended-release tablets, 25 mg and 50 mg and is therefore eligible for 180 days of shared generic drug exclusivity for the drug, it added. Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urinary incontinence, urgency and urinary frequency. The drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, the filing added. As per

Lupin gets USFDA approval to market anti-epilepsy drug in US market

Drug firm Lupin on Friday said it has received approval from the US health regulator to market its anti-epilepsy drug Vigabatrin for Oral Solution in the American market.

Zydus Lifesciences gets USFDA nod for generic drug to treat chest pain

Zydus Lifesciences on Wednesday said it has received approval from the US health regulator to market Nitroglycerin Sublingual tablets, used to treat chest pain, in the American market.

Multiple near-term concerns trigger Divi's Laboratories' headache

Pfizer's oral Covid drug, weak sales of generics, and valuations may cap upsides

Drug firm Lupin launches generic Fenofibrate capsules in United States

Lupin on Wednesday said it has launched the capsules

Dr Reddy's, Natco Pharma launch generic cancer drug in Canada

Dr Reddy's Laboratories and Natco Pharma on Thursday said they have launched generic capsules used in the treatment of multiple myeloma and myelodysplastic syndrome patients in the Canadian market.

Lupin launches generic antifungal Tavaborole Topical Solution in US market

Drug maker Lupin on Tuesday said it has launched antifungal product Tavaborole Topical Solution in the US market.

Five pharmaceutical companies get approval to make black fungus drug

These developments come amid fast spread of the disease in various states and shortage of drugs to treat them.

Amid weak showing by biosimilars and generics, downgrade pressure on Biocon

Analysts expect ramp-up in biosimilars to be gradual

Biocon partners with Libbs Farmaceutica to launch generic drugs in Brazil

Biotechnology major Biocon on Monday said its subsidiary has joined hands with Libbs Farmaceutica to launch generic drugs in Brazil, the world's sixth most populous country.

Biocon posts 19% dip in Q3 net profit as generics biz takes a hit

Biocon's consolidated revenue for Q3 of FY21 increased by 7.20 per cent at Rs 1878.9 crore as against Rs 1752.6 crore for the said quarter last year