HOME > BUSINESS > Zydus Cadila gets USFDA approval for generic version of popular migraine drug

Zydus Cadila gets USFDA approval for generic version of popular migraine drug

Zydus Cadila said it received final approval from the US Food and Drug Administration to market migraine drug Eletriptan Hydrobromide in the US.

The drug is currently marketed and manufactured by Pfizer Inc and sold in the US and Canada under the brand name Relpax.

The two key patents covering the drug are listed as scheduled for expiration on December 26, 2016, and August 29, 2017.

The drug which is used in the treatment of migraine, will be produced at the group’s formulations manufacturing facility at the Pharma SEZ in Ahmedabad.

The approval is for tablets of 20 mg and 40 mg dosage.

Eletriptan was approved by the U.S. in 2002 and is available only by prescription in the United States and Canada.

Zydus Cadila now has more than 120 approvals and has so far filed over 300 abbreviated new drug applications since the commencement of the filing process in FY 2003-04.

Eletriptan is believed to reduce swelling of the blood vessels surrounding the brain. This swelling is associated with the head pain of a migraine attack.

The drug blocks the release of substances from nerve endings that cause more pain and other symptoms like nausea, and sensitivity to light and sound.

Follow ULTRA.news
Neuland Laboratories acquires Hyderabad factory from Arch Pharma Pharma manufacturer Neuland Laboratories said it acquired a manufacturing plant located near Hyderabad from Arch Pharma Labs Limited.The facility is spread across 12 acres and has a capacity of about 197 KL, the company said.The plant was inspected by the USFDA in 2015, ...
DENGUE DEATH: Haryana govt probe finds Fortis Hospital guilty An official inquiry by the Haryana government has found the Gurgaon Fortis hospital guilty of overcharging and several other violations of law, media outlets reported.Quoting the official copy of the report, Mirror Now said that the inquiry committee found the hospital guilty...
Eris Lifesciences completes acquisition of Strides Shasun India generics ops Pharma company Eris LifeSciences said it has completed its purchase of the India branded generics of Strides Shasun for Rs 500 cr in cash."We now wish to confirm that the transaction ahs achieved closure," said Eris Lifesciences.Last month, Strides Shasun said it was sel...
Crucial win for Biocon as FDA approves cancer biosimilar trastuzumab Biocon and its partner Mylan scored a key victory on Friday as the US Food & Drug Administration approved its cancer-treating biosimilar trastuzumab."Mylan anticipates potentially being the first company to offer a biosimilar to Herceptin, as a result of Mylan's ability to s...
Boosted by Jio’s success, Mukesh Ambani unveils his future plans Mukesh Ambani, India's richest man, said telecom was the first of his big bet, and he will now use his resources to solve problems in three other difficult areas -- agriculture, education and healthcare.Speaking at the HT Leadership Summit, Ambani said his primary motivation...
Glenmark registers first inhaler product in Europe Glenmark Pharmaceuticals said it has registered its Seretide Accuhaler product in the Nordic region of Europe, including Sweden, Denmark, Norway, Finland and Iceland."The commercialization of the product would depend on national approval as well as substitution and pricing ...
EU accepts Biocon, Mylan’s application for cancer biosimilar pegfilgrastim Indian pharma company Biocon and its partner Mylan said EU authorities have accepted for review their applications for approving cancer treating biosimilars trastuzumab and pegfilgrastim submitted after completing corrective actions.The applications were resubmitted last mo...
Dr Reddy’s says EU approves production at Duvvada plant in Andhra Pharma major Dr Reddy's Laboratories said European Union authorities have again allowed it to produce drugs for sale in the EU region at its Duvvada factory in Andhra Pradesh.In its inspection conducted in September, the Regulatory Authority of Germany (Regierun von Oberbayer...
Panacea Biotec gets US nod for generic version of cancer drug Abraxane Panacea Biotec said it got the regulatory nod in the US for launching a generic version of big-selling cancer drug Abraxane.The drug will be sold with the help of Canadian pharmaceutical distributor Apotex.The annual sale of Abraxane worldwide is approximately US$973.4 m...
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 ...
Dr Reddy’s gets served with class action lawsuit Pharma major Dr Reddy's Laboratories said it has been served with a class action lawsuit, originally announced in August, related to public disclosures made about regulatory action against the company."Further to our intimation dated August 28, 2017 with regard to US Securit...
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 ...
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 Nor...
Strides Shasun gets USFDA nod to launch nausea drug Strides Shasun Limited said it received approval from the United States Food & Drug Administration (USFDA) to launch a generic version of Diamox Tablets.The primary use of the Acetazolamide is to reduce nausea and dizziness associated with altitude sickness, but the drug is ...
After Lupin, Ajantha Pharma too launches generic ADHD drug in US A month after Lupin got it, Ajanta Pharma too said it got the approval to launch a generic version of Concordia Pharmaceuticals Inc.’s ADHD drug Kapvay.Lupin had got the nod in October, and said the drug had sales of around $66 mln in the US.Ajantha Pharma also said it ha...
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...
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...
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, conges...
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 equivalent...
Suven Life Sciences gets patents in USA, India and Hong Kong Pharma company Suven Life Sciences Ltd said it received new patents in India, USA and Hong Kong for neurological drugs.The patents -- one each in Hong Kong and the US and a couple in India -- are valid through 2032, 2030 and 2034."The granted claims of the patents include...