Page 4 - Generic Drugs

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

Making markets work for affordable medicines

Regulatory safeguards to ensure quality and efficacy of drugs are a necessary pre-condition for effective competition between generic and branded drugs

Pharmacy consolidation may disrupt domestic drug market: Credit Suisse

The report says if chemists are allowed to replace doctor's prescription with a generic drug, firms with high exposure to chronic therapeutic drugs will be impacted more

India seeks new preferential treatment from US on drugs, other goods

India accounts for 40 per cent of US generic drug imports, including the anti-malarial hydroxychloroquine, touted by US President Donald Trump in the fight against Covid-19.

Zydus Cadila gets USFDA nod to market generic drug to treat headache

The drug will be manufactured at Nesher Pharma's manufacturing facility at St. Louis in the US, the drug firm says

US charges generic drug firm Glenmark with conspiracy in price-fixing

Company says it strongly disagreed with the charge, has 'overwhelming evidence' to support its innocence.

First copies of Gilead coronavirus drug to start selling in Bangladesh

The Dhaka-based Beximco, which counts Norges Bank as one of its investors, will sell remdesivir for about 6,000 taka ($71) a vial to private clinics but will give it free to state-run hospitals