Glenmark Pharma to launch birth control pill in USA

Glenmark Pharmaceuticals said it got the approval of the United States Food & Drug Administration to launch a generic version of birth control pill Loestrin from Allergan Pharmaceuticals International. The drug had annual sales of approximately $116.8 million. The drug Norethindrone Acetate and Ethinyl Estradiol Tablets will be sold in the 1/20 dosage. Glenmark’s current […]

Cipla gets US approval for cancer drug, Glenmark for oral contraceptive

Two Indian pharmaceutical companies, Cipla and Glenmark, said they received approval from the US Food and Drug Administration for new drugs. While Cipla got the nod for a drug used to treat a type of blood cancer, Glenmark was approved to sell an oral contraceptive. Cipla got approval to sell a generic version of Otsuka […]

Strides Shasun says Eris deal to help reprioritize business, lower debt

Pharma major Strides Shasun said it agreed to sell its India branded generics business to Eris LifeSciences Limited for Rs 500 cr in cash. “This transaction is the outcome of the company’s portfolio reprioritization, to focus more sharply on larger regulated markets,” it said. The India branded generics business being divested by Strides had sales […]

Zydus gets nod for anti-inflammation drug in the US

Pharma major Zydus Cadila said it received final approval from the USFDA to market an anti-inflammatory injection Ethacrynate Sodium in the US. The drug is used to decrease the Swelling (edema) caused by various disease conditions such as liver disease, kidney disease, congestive heart failure, cancer etc. and will be produced at the group’s formulations […]

Cipla launches ashtha inhaler therapy in the US

Pharma giant Cipla Ltd said it received final approval for launching a generic version of Astrazeneca’s Pulmicort inhalation suspension for pediatric asthma in the US. The product is available for shipping immediately, Cipla said. Pulmicort Respules and generic equivalents had U.S. sales of approximately $825M for the 12- month period ending September 2017, making them […]

Zydus Cadila gets approval for cholesterol drug in Mexico

Zydus Cadila said Mexico’s drug regulator granted marketing approval to market its diabetes drug Lipaglyn in Mexico. The drug can be used to bring down cholesterol levels in patients even when conventional therapies like statins fail. “This approval of Saroglitazar in Mexico is a major milestone for the company,” said Chairman Pankaj Patel. Lipaglyn was […]

Lupin gets USFDA warning on Goa, Indore plans, to affect new approvals

Pharma major Lupin said it a warning letter from the US Food and Drug Administration for its formulations manufacturing facilities in Goa and Indore on Monday. “We are deeply disappointed to hove received this outcome. While there will be no disruption of existing product supplies from either of these locations, there will likely be a […]

Biocon, Mylan apply again for EU approval for cancer drugs trastuzumab, pegfilgrastim

Biocon said its partner Mylan has resubmitted the marketing application for two substances used to treat cancer — trastuzumab and pegfilgrastim — before European authorities after making changes to their production facilities. The drug applications before the European Medicines Agency (EMA) were withdrawn in August after the authorities refused to issue approval without reinspecting the […]

Alembic Pharma buys US-based generics manufacturer

Alembic Pharmaceuticals said it bought New Jersey-based generic drug developer Orit Laboratories LLC, which will bring seven approved generics and four applications with it. Orbit has “a team of eight highly experienced scientists,” Alembic said, adding that the firm focuses on developing and filing oral solid and liquid products. “We Welcome Dr. Satish Patel, Founder […]

Cipla gets USFDA nod to launch kidney drug in the US

Pharma giant Cipla said it received final approval to market a generic version of Genzyme’s kidney drug Renvela Tablets in the US. Renvela Tablets had US sales of approximately $1.85 billion for the 12-month period ending August 2017, according to IMS Health. The approval is for Sevelamer Carbonate Tablets, 800 mg, which is an AB-rated […]

Lupin gets USFDA approval for generic ADHD drug

Pharma Major Lupin said it received final approval from the United States Food and Drug Administration (FDA) to market a generic version of Concordia Pharmaceuticals Inc.’s ADHD drug Kapvay. It had annual sales of approximately USD 66 million in the US. Clonidine Hydrochloride, the AB rated generic equivalent, is used for the treatment of attention […]

Lupin buys US-based vaginosis drug maker for $150 mln

Pharma major Lupin said that its US subsidiary, Lupin, Inc has acquired Symbiomix Therapeutics, LLC for a cash consideration of USD 150 million including a USD 50 million upfront and other time‐based payments. In addition, there are sales based contingent payments. Lupin had entered into an option to acquire the company earlier this year. Symbiomix […]

Suven Life Sciences gets patent for neuro drug

Suven Life Sciences Ltd said it was granted a patent by New Zealand authorities for “a class of selective 5-HT4 compounds” that are being developed to treat neurodegenerative diseases. The compounds are being explored for use in cases of Alzheimer’s disease, Attention deficient hyperactivity disorder (ADHD), Huntington’s disease, Parkinson and Schizophrenia, it said. The new […]

USFDA returns Mylan-Biocon’s drug application for more data

The U.S. Food and Drug Administration has sought more data before approving a chemotherapy compound submitted by Mylan and jointly developed by Biocon. The agency issued a ‘complete response letter’. Such letters are issued when an FDA review an FDA review finds that an application for a new drug cannot be approved ‘in its present […]

Zydus Cadila gets USFDA nod for overactive bladder drug

Zydus Cadila said it received the final approval to launch overactive bladder drug Fesoterodine Fumarate in the US. The sales of Fesoterodine Fumarate Extended-Release Tablets are estimated at $195.5 million. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad. Fesoterodine is used to treat an overactive bladder with Symptoms of urinary […]