Lupin receives tentative approval from FDA for Ivacaftor tablets

Ivacaftor Tablets had estimated annual sales of USD 109 million in the US.

Zydus Lifesciences receives USFDA approval for Adapalene and Benzoyl Peroxide Topical Gel

The drug will be manufactured at the group’s topical facility at Ahmedabad

FDA publishes ANP’s polymeric drug excipient DMF

The DMF#36513 demonstrates ANP’s success in the development of its “Plug and Play” drug delivery platform.

ENTOD Pharmaceuticals gets DCGI nod to carry out the phase 3 trials of 0.05% atropine eye drops

Low-dose atropine has emerged as an effective approach to slow the progression of myopia in children

USFDA accepts dupilumab for priority review in adults with prurigo nodularis

Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., if approved

FDA approves Roche’s Evrysdi for use in babies under two months with SMA

Evrysdi has proven efficacy in babies, children and adults with more than 5,000 patients treated to date

Mezzion Pharma receives clear FDA path forward for the approval of Udenafil for single ventricle heart disease

US FDA accepts new drug application filed by Avillion for AstraZeneca's PT027

Avillion announces expansion of partnership with AstraZeneca on PT027 and will fund and execute a new Phase 3b study

Strides receives USFDA approval for Ibuprofen Oral Suspension

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Motrin Oral Suspension, 100 mg/5 mL, of McNeil Consumer Healthcare (McNeil)

USFDA approves Omeprazole capsules to prevent heartburn

Perrigo expects to launch Omeprazole Minis later this year

Eugia Pharma receives USFDA approval for Pemetrexed

Pemetrexed for injection is indicated for the treatment of Antineoplastics (medications used to treat cancer)

Zydus Lifesciences receives final approval from USFDA for Pemetrexed for Injection

Pemetrexed for Injection has a market size of USD 1,236 mn (as per IQVIA MAT March’22)

European Commission approves Keytruda plus chemotherapy as neoadjuvant treatment for breast cancer

This Keytruda combination is the first immunotherapy option approved in the EU for high-risk early-stage TNBC

Cadila Pharma launches Belmore to treat uncontrolled LDL-cholesterol

Belmore, the brand name of Bempedoic acid, is a novel drug for the treatment of high LDL-cholesterol.

Alembic Pharmaceuticals receives USFDA final approval for Pirfenidone tablets

The tablets have an estimated market size of US $ 548 million for twelve months ending December 2021 according to IQVIA

Vaxzevria approved in the EU as third dose booster against Covid-19

Approval follows CHMP recommendation for use in patients previously vaccinated with Vaxzevria or an EU-approved mRNA Covid-19 vaccine

CHMP recommends European Commission approval of Rinvoq

Ulcerative colitis is a chronic, immune-mediated inflammatory bowel disease that can lead to substantial burden and often disability among patients

USFDA approves Dupixent as first treatment for 12 and older with eosinophilic esophagitis

Dupixent is the first and only medicine indicated to treat eosinophilic esophagitis in the United States; approval granted more than two months ahead of USFDA’s Priority Review action date

Glenmark receives sANDA approval for Abiraterone Acetate tablets

According to IQVIA sales data for the 12-month period ending March 2022, the Zytiga tablets, 500 mg market achieved annual sales of approximately US $ 260.2 million

Biocon Biologics and Viatris launch Abevmy in Canada

Abevmy follows the launch of the company’s two oncology biosimilars in Canada, Ogivri (bTrastuzumab) in 2019 – the first Trastuzumab approved in the country – and Fulphila (bPegfilgrastim), which was launched in 2020