Glenmark, Cipla get US nod for inhaler drug

Indian pharmaceutical manufacturers Cipla and Glenmark Pharma said they received approval from the US Food and Drug Administration to launch a generic version of Sunovion Pharma’s inhaler therapy Brovana. The drug has substantial sales in the US of around $438 million in the 15 mcg dose and is approved for long-term, twice daily usage for […]

Cipla launches generic Sensipar amid legal battle with Amgen

Pharmaceutical major Cipla and its subsidiary Cipla USA announced the phased launch of a generic therapeutic equivalent version of Sensipar, a branded drug manufactured by Amgen Inc. The launch, however, is a subject of ongoing litigation, Cipla said in a regulatory filing. Amgen’s Sensipar generated US sales of $1.43 billion in 2018. Cinacalcet hydrochloride tablets […]

Cipla wins approval for generic testosterone in the US

Drug maker Cipla said it received final approval for selling a generic testosterone injection in the US. Cipla’s Testosterone Cypionate Injection 100mg /ml and 200mg /ml is an AO-rated generic equivalent version of Pharmacia and Upjohn’s Depo-Testosterone. Depo-Testosterone and its generic equivalents h ad US sales of approximately $191 M, according to IQVIA. The drug […]

Cipla dismisses concerns over FDA observations on Goa plant

Pharma major Cipla dismissed concerns about adverse observations by the US Food and Drug Administration on one of its manufacturing plants in Goa. The Goa plant is one of the company’s largest manufacturing locations for exports, and the observations could affect the company’s trade with the US, media reports had said. The company’s stock fell […]

Cipla, Strides Shasun launch HIV drug in the US after patent expires

Cipla and Strides Shasun, two Indian pharmaceutical companies, both said they have started shipping generic versions of Gilead Sciences’ HIV drug Viread after patent protection expired last week. Viread is among the bigger pharmaceutical drugs in the US and has sales of around $725 mln (Rs 4,650 cr) in the US every year. The patent […]

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 […]

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 […]

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 […]