Biocon Ltd today announced that the U.S. Food and Drug Administration (USFDA) has issued a Complete Response Letter (CRL) for the company’s Biologics License Application (BLA) seeking approval for its proposed biosimilar bevacizumab. Bevacizumab is an anti-cancer drug used to treat various types of cancers. Biocon has developed a biosimilar version of bevacizumab under the […]
Pharmaceutical company Ipca Laboratories announced that its formulations manufacturing facility in Pithampur, Madhya Pradesh has passed a quality inspection by the US Food and Drug Administration (USFDA) and received a Voluntary Action Indicated (VAI) status. A VAI status implies that the USFDA found certain non-critical issues at the facility which require remedial action from the […]
Alembic Pharmaceuticals said it received tentative approval from the US Food & Drug Administration to launch a generic form of blood pressure tablet Opsumit. The tablet, including generic forms such as macitentan, is one of the bigger sellers in the market with estimated annual sales of $797 mn. Most of the generic drugs sold by […]
Sun Pharmaceutical Industries said it has received Emergency Use Authorization or EUA from India’s Drugs Controller General of India (DCGI) to manufacture and market a generic molnupiravir in India, a week after the US-FDA gave an EUA to its use in the US. The company has promised to make the oral drug, under the brand […]
Zydus Cadila said it received tentative approval from the USFDA to market Pimavanserin tablets — a generic form of Acadia Pharmaceuticals’ Nuplazid — in the US. Tentative approval refers to approval given ahead of patent expiry. The company will be able to start selling the drug only when the patent protection expires. The compound, as […]
Morepen Laboratories said it expects its US export business to get a major boost now that the US FDA has given it the go-ahead to export allergy drug Allegra to that market. Fexofinadine, invented by Sanofi Aventis, is the most widely used, second generation antihistamine drug for the treatment of allergy symptoms and hay fever, […]
Biopharmaceuticals manufacturer Biocon Ltd launched cancer medication Everolimus tablets in the US. The formulation, a generic version of Afinitor from Novartis, is a prescription medication that is used to treat certain types of cancers and tumours. The tablet has annual sales of around $675 mln in the US, which makes it among the larger drugs […]
Six months after getting a VAI status from the US Food & Drug Administration for its insulin glargine manufacturing facility in Malaysia, Biocon — India’s largest biopharmaceuticals company — said the US FDA issued six observations after pre-approval inspections at its insulin aspart plant in that country. Insulin glargine is a long-acting insulin-substitute, while insulin […]
Zydus Cadila said it received approval from the US Food & Drug Administration to sell new generation anti-depressant Vortioxetine in the US market. The drug was first approved around seven years ago, and was developed by Denmark-based pharmaceuticals maker Lundbeck in the late 2000s. Around 2007, Japanese pharmaceuticals maker Takeda agreed to pay an upfront […]
Zydus Cadila said it received six-month exclusivity for the sale of generic tofacitinib, a drug that has annual sales of over $2 billion in the US. The exclusivity was provided by the US FDA, since Cadila Healthcare was the first to file an abbreviated new drug application or ANDA for the drug. An ANDA is […]
Pharmaceuticals manufacturer Alkem Laboratories said its bioequivalence center at Taloja in Maharashtra has successfully undergone a US FDA inspection without attracting any adverse remarks. “US FDA had conducted a remote and virtual Bio-Analytical inspection of the Company’s Bioequivalence Center located at Taloja, Maharashtra from 26th July, 2021 to 28th July, 2021. At the end of […]
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 […]
Lupin Ltd, one of the world’s largest generic drug makers, today said it received a warning letter from the US Food and Drug Administration relating to its US-based manufacturing plant located in Somerset, New Jersey. “We wish to inform you that the Company has received a warning letter from the US FDA for the company’s […]
Alembic Pharmaceuticals said a new chemical developed by one of its joint ventures has become the first new chemical entity designed by Indian scientists to win approval from the US Food & Drug Administration. Umbralisib, created by its 50% JV Rhizen Pharma, is an anti-cancer drug that works by inhibiting phosphoinositide 3 kinase (PI3K) delta […]
Aurobindo Pharma Ltd has said that the US FDA has lined up one of its oral solids formulation plants in Telangana for regulatory action, following adverse findings in an October inspection. The company’s shares had fallen by 19% in intra-day trading on October 8, soon after the company disclosed that FDA inspectors had made seven […]
The US Food and Drug Administration has issued a Form 483 with five observations for Biocon’s API Manufacturing facility. Form 483 observations are issued when US FDA inspectors notice shortcomings in a company’s manufacturing processes, data storage and so on during an inspection. The company has to address the issues raised in the Form 483 […]
Alembic Pharmaceuticals, one of India’s biggest drug makers, received two observations from US FDA officials who inspected its plant at Karkhadi in Gujarat. Observations, given in Form 483, indicate that the inspectors were not fully satisfied with what they found during the visit. In a Form 483, the FDA typically outlines conditions or practices at […]
India-based Natco Pharma has filed an application with the US Food and Drug Administration seeking permission to market a generic copy of Lonsurf, a drug approved just four years ago to treat colorectal/gastric cancers. The application has been filed with a ‘Paragraph IV’ declaration. Such a declaration essentially states that the filer, Natco, believes that […]
Cadila Healthcare, one of India’s biggest pharmaceutical companies, said it has received a ‘warning letter’ from the US Food and Drug Administration relating to its Moraiya formulations facility in Gujarat. The Moraiya facility is the company’s largest plant that makes tablets and injectables and is estimated to contribute about 40-50% of its U.S. exports. Shares […]
Cadila Healthcare today said that the US FDA has classified its Moraiya factory near Ahmedabad as ‘official action indicated’ or OAI. OAI is one of the three types of classification that a plant inspection report is put under after an FDA inspection. The three classifications are ‘no action indicated’, ‘voluntary action indicated’ and ‘official action […]
