HOME > BUSINESS > Lupin gets FDA nod for generic cholesterol drug

Lupin gets FDA nod for generic cholesterol drug

Pharmaceuticals company Lupin said it received a 505 (b)(2) NDA approval for its Nikita”M (Pitavastatin) Tablets 1 mg, 2 mg and 4 mg from the United States Food and Drug Administration (FDA).

A 505(b)(2) approval refers to one given by relying on studies already performed on a previously approved drug.

The product is an alternate salt product of Kowa Company Ltd’s Livalo (Pitavastatin Calcium) Tablets.

It will target patients with primary hyperlipidemia or mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol, lowdensity lipoprotein cholesterol, apolipoprotein B, triglycerides and to increase high-density lipoprotein cholesterol.

Livalo tablets had US sales of USD 272 million.

Lupin is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, Gl, Anti-infective and NSAID space and holds global leadership position in the Anti-TB segment.

Lupin is the sixth largest generics pharmaceutical company by revenue and the fourth largest pharmaceutical player in the US by prescriptions.

For the financial year ended 31 March, 2017, Lupin’s Consolidated sales and Net profit stood at Rs. 171,198 million (USD 2.55 billion) and Rs. 25,575 million (USD 381 million) respectively.

Follow ULTRA.news
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 h...
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 deficie...
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 appli...
Lupin gets FDA nod to launch heart drug in the US Pharma manufacturer Lupin said it received approval to launch the generic version of US World Meds' Corgard heart drug.Nadolol Tablets USP, 20 mg, 40 mg, and 80 mg Tablets had annual sales of approximately USD 109.8 million in the US, the Indian drugmaker said.Lupin's N...
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 manufacturin...
NATCO Pharma to sell multiple sclerosis drug in USA via Mylan NATCO Pharma Limited said it the US Food and Drug Administration approved the generic drug application filed by its marketing partner Mylan for injections used in the treatment of multiple sclerosis, a chronic inflammatory disease of the central nervous system.The drug, Glat...
Vivimed pharma unit gets Rs 270 cr investment from OrbiMed fund Pharmaceuticals and specialty chemicals maker Vivimed Labs said investment firm OrbiMed will invest $42.5 mn (Rs 270 cr) into its active pharmaceutical ingredients business.The investment will be into Vivimed Labs Mascarene Ltd, which is in turn the holding entity of the com...
Glenmark to launch Desonide topical ointment in US Glenmark Pharmaceuticals Inc said it has got the go-ahead to launch the generic version of Perrigo's anti-inflammation ointment Desonide Ointment in the US.Desonide Ointment, 0.05% had annual sales of approximately $23.4 million for the 12 month period ending July 2017, acco...
Biocon passes US-FDA inspection at Vishakapatanam plant Biocon said the plant inspection conducted by the US Food and Drug Administration at its Vishakapatanam plant passed without incident."US FDA inspected our Active Pharmaceutical Ingredients (API) manufacturing facility in Wishakhapatnam, Andhra Pradesh from September 11 to 1...
Zydus Cadila gets approval for two drugs in the US Zydus Cadila said it received the final regulatory approval to market anti-sleep drug Modafinil in the US, and tentative approval for bladder control drug Solifenacin Succinate.Unlike a final approval, tentative approvals don't allow the grantee to sell the drugs in the US m...
Lupin gets nod to launch Metronidazole antibiotic in the US Lupin said it received final approval to market a generic version of G.D. Searle LLC Flagyl antibiotic tablets in the US.Flagyl tablets had US sales of USD 44.1 millionLupin’s Metronidazole Tablets USP, 250 mg and 500 mg are the AB rated generic equivalent of the drug. ...
Lupin gets UDFDA nod for generic version of Pfizer’s acne drug Pharma company Lupin said it received final approval from the US Food and Drug Administration for launching a generic version of Pfizer Inc.'s acne drug Vibra-Tabs.Doxycycline Hyclate Tablet 100 mg had US sales of USD 149.9 million per year, the company said.Doxycycline ...
Panacea Biotec to supply heart drug to Apotex for US market Pharma company Panacea Biotec said it has signed an agreement to supply a generic version of Eli Lilly's Effient heart drug to Apotex, the largest Canadian-owned pharmaceutical company.The drug will be sold by Apotex in the US market."Under the terms of the agreement, Ap...
Zydus Cadila to launch immuno-suppressant in the US Pharma giant Zydus Cadila said it received final approval from the USFDA to market immunonsuppressant Mycophenolate Mofetil injection.The drug is indicated for use in combination with other drugs i.e., cyclosporine and corticosteroids for the prophylaxis of organ rejection ...
Jubilant Life Sciences gets US-FDA approval for pain drug Pharma company Jubilant Life Sciences Ltd said it received final approval to sell pain drug Indomethacin in the US.The drug, which is also sold as Indocin by Iroko in the US, is a nonsteroidal anti-inflammatory drug used for the treatment of moderate to severe inflammation a...
Glenmark Pharma gets USFDA approval for generic version of Mylan’s anti-inflammation ointment Glenmark Pharmaceuticals said it has got the US FDA approval to sell the generic version of corticosteroid ointment Kenalog from Mylan Pharmaceuticals.The primary ingredient is triamcinolone, a corticosteroid that reduces the actions of chemicals in the body that cause inflam...
Zydus Cadila gets USFDA nod for chemo, BP drugs Zydus Cadila said it has received approval from the US Food and Drug Administration to market chemotherapy drug Temozolomide and blood pressure drug Nadolol.Temozolomide will be made available in six doses from 5 mg to 250 mg.It is used in the management of brain tumors....
Strides Shasun to launch allergy drug in the US Pharma company Strides Shasun said it had received approval allergy drug Cetirizine Hydrochloride in the US."The US market for Cetirizine Hydrochloride Capsules (Softgel) is approximately USD 60 mln, with only one other generic player," the company said."The product is re...
Glenmark gets US FDA approval for generic version of Daiichi Sankyo’s hypertension drug Glenmark Pharmaceuticals said it got approval from US authorities to launch a generic version of Daiichi Sankyo's hypertension drug Azor in various dosages.The drug had annual sales of approximately $211.6 million as of May.The approval was obtained from United States Foo...
Lupin launches eye drug in the US Pharma company Lupin said it launched Moxifloxacin Hydrochloride eye solution in the US.Lupin's Moxifloxacin Hydrochloride Ophthalmic solution USP, 0.5% (base), is an AT1 rated generic equivalent of Novartis Pharms Corp.'s Vigamox Ophthalmic solution.It is indicated for...