Zydus Cadila receives tentative USFDA nod for overactive bladder drug

Pharmaceutical manufacturer Zydus Cadila said that it has received tentative approval from the US Food and Drug Administration for sales of mirabegron extended-release tablets. A tentative approval means that the company has to wait for all patent and other protections to expire before starting the sale of the drug. The tablets, currently sold under the […]

Zydus Cadila receives US nod for generic version of Gilead Sciences’ Letairis

Pharmaceutical manufacturer Zydus Cadila said that it has received approval from the United States Food and Drug Administration for the sales of a generic equivalent of Gilead Sciences’ hypertension drug Letairis. Ambrisentan tablets had sales of $943 million in the US market in 2018, marking it among the bigger drugs in the market. Ambrisentan tablets […]

Lupin, Unichem, Alembic & Zydus okayed to sell generic Cialis in US

Indian pharmaceutical manufacturers Lupin, Unichem Laboratories and Alembic Pharmaceuticals said that they has received approval from the United States Food and Drug Administration to sell generic versions of Eli Lilly’s Cialis erectile dysfunction tablets, while rival Zydus Cadila said it has already begun selling the tablets on day 1. The patent for Cialis, owned by […]

Zydus Cadila gets USFDA approval for schizophrenia drug

Pharmaceutical manufacturer Zydus Cadila said it received final approval from the United States Food and Drug Administration for sales of a generic version of Sunovion Pharmaceuticals’ Latuda tablets. Lurasidone tablets are used to treat certain conditions associated with bipolar disorder such as schizophrenia and depression. It also helps to decrease hallucinations. The drug will be […]

Zydus Cadila gets USFDA nod for generic Zovirax ointment for herpes

Pharmaceutical manufacturer Zydus Cadila said that it received final approval from the United States Food and Drug Administration for the sale of a generic version of Valeant’s Zovirax ointment. Acyclovir, belonging to a class of medications called antivirals, is used to treat cold sores or fever blisters caused by herpes viruses. The ointment will be […]

Zydus Cadila gets USFDA nod for potassium chloride tablets

Pharmaceutical manufacturer Zydus Cadila said it received final approval from the US Food and Drug Administration for the sales of Potassium Chloride extended-release tablets for the treatment of various diseases such as prolonged diarrhoea and vomiting, hormone problems such as hyperaldosteronism and diuresis. The tablet, sold under the brand names Klor-Con, K-Dur and Micro-K, is […]

Zydus confirms Heinz India buy for Rs 4,595 cr; gets Complan, Glucon D

Zydus Wellness, the consumer healthcare arm of Zydus Cadila, said it has agreed to acquire Heinz India Private Ltd, the Indian unit of global FMCG major Kraft Heinz. The transaction, which will be carried out in association with Cadila Healthcare Ltd, values Heinz India at Rs 4595 cr, the company said. Heinz India’s business comprises the brands Complan, Glucon D, […]

Zydus Cadila gets USFDA approval for cholesterol, psychosis drugs

Zydus Cadila said it received the final approval from the USFDA to market cholesterol-lowering Gemfibrozil and antipsychotic Aripiprazole in the US. Gemfibrozil Tablets are used together with diet to treat very high cholesterol and triglyceride levels in people with pancreatitis. It is also used to lower the risk of stroke, heart attack or other heart […]

Zydus Cadila gets tentative US approval for iron excess drug

Zydus Cadila said it has received tentative regulatory approval from the US Food & Drug Administration for selling Deferasirox, used to chelate or expel excess iron from the blood. The drug is sold under names such as Exjade, Desirox, Defrijet, Desifer, Rasiroxpine and Jadenu. Tentative approval means that the company has to wait for all […]

Zydus receives US nod for generic Cialis ahead of patent expiry

Zydus Cadila, one of India’s largest drug makers, said it has received tentative approval to market tadalafil, the generic ingredient of the most popular erectile dysfunction drug Cialis, in the US market. The drug will be manufactured at the group’s facility at Moraiya, Ahmedabad. The USFDA approval comes weeks before Cialis is expected to lose patent […]

USFDA completes inspection at Zydus’ Ahmedabad plant

Pharmaceuticals maker Zydus Cadila said the USFDA has completed an inspection of its injectables manufacturing plant at Ahmedabad with zero observations. No observations is good news for pharma manufacturers as it indicates that the inspectors found everything to order. The inspection of the plant, located at an SEZ in the city, was conducted between May […]

Zydus Cadila gets USFDA nod for NSAID Diclofenac Sodium

Pharmaceuticals maker Zydus Cadila said it received the final approval from the USFDA to market inflammation solution Diclofenac Sodium in the country. Diclofenac Sodium topical solution, 1.5%, is a non-steroidal anti-inflammatory drug (NSAID) used for symptomatic treatment of osteoarthritis of the knee. It will be manufactured at the group’s Topical manufacturing facility at Ahmedabad, the […]

Glenmark launches anti-inflammation drug based on Adalimumab

Glenmark Pharmaceuticals said it has launched a biosimilar of Adalimumab, a drug for Plaque Psoriasis and Rheumatoid Arthritis from Cadila Healthcare Ltd.. “The launch of ADALY marks the launch of Glenmark’s first biosimilar in Dermatology,” the company said. The drug has been licensed from Cadila. “ADALY will be available to patients in India at a […]

ICMR, Zydus launch diagnostic kits for infectious diseases

Government of India-funded Indian Council of Medical Research (ICMR) and private sector player Zydus have announced the launch of new diagnostic kits that can help in detecting Japanese Encephalitis Virus in mosquitoes and the Crimean-Congo Haemorrhagic Fever in sheep, goat and cattle. The kits are the result of the research and development conducted by ICMR […]

Zydus Cadila gets USFDA nod to launch generic version of billion-dollar drug Cialis eventually

The United States Food and Drug Administration has given Zydus Cadila approval to launch a generic version of the billion-dollar erectile dysfunction drug Cialis when patents expire. The patents are expected to expire in September next year. Cialis and Viagra are the most popular erectile dysfuntion drugs in the world. Cialis, created by Eli Lilly, […]