Aurobindo, Zydus, Jubilant, others recall various products in US market

 Indian drug firms like Marksans Pharma, Aurobindo Pharma, Zydus and Jubilant are recalling products in the US market, as per the latest enforcement report by the US Food and Drug Administration (USFDA).

While Marksans Pharma is recalling diabetes drug, Zydus Pharmaceuticals (USA) is recalling drug which is used to reduce stomach acid.

Similarly,Aurobindo Pharma (USA) is recalling pain relieving drug, while Jubilant Cadista is recalling a medication used to treat schizophrenia.

As per the USFDA, Marksans Pharma is recalling close to six lakh bottles of diabetes drug Metformin Hydrochloride extended-release tablets in strengths of 500 mg and 750 mg in the US market.

The medication lot has been manufactured at the company's Goa-based manufacturing facility.

As per the USFDA, the company is recalling the product due to deviation from the current good manufacturing practices (CGMP).

"FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level," it noted.

NDMA has been defined as a probable human carcinogen.

Metformin Hydrochloride extended-release tablet is a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type-2 diabetes mellitus.

Various companies across the globe have announced similar recalls for the product after the USFDA pointed out presence of NDMA above permissible limits.

FDA's testing has shown elevated levels of NDMA in some extended release (ER) metformin formulation, but not in the immediate release (IR) formulation or in the active pharmaceutical ingredient.

NDMA is classified as a probable human carcinogen based on results from laboratory tests. It is a known environmental contaminant and found in water and food, including meats, dairy products and vegetables.

Further, the USFDA said Zydus Pharmaceuticals (USA) is recalling 14,748 cartons of Lansoprazole delayed-release orally disintegrating tablets due to failed dissolution specification. The product has been manufactured by Ahmedabad-based Cadila Healthcare.

The USFDA has classified the initiatives taken by Marksans and Zydus as class II recalls.

As per the USFDA, a class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Further, the US health regulator said Aurobindo Pharma USA is recalling 7,440 bottles of Ibuprofen oral suspension drug for labelling error.

Besides, Jubilant Cadista Pharmaceuticals, Inc is recalling 23,616 blister packs of Olanzapine orally disintegrating tablets for being "subpotent", the USFDA noted.

The recalled lot has been produced by Roorkee-based (Uttarakhand) Jubilant Generics.

The US health regulator classified both the recalls as class III.

As per the USFDA, a class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences".

USFDA accepts Biocon-Mylan's Avastin biosimilar application for review

In a positive for Biocon, US drug regulator USFDA has accepted a biologics licence application by biopharmaceutical major and partner Mylan for a proposed biosimilar to treat advanced colon or rectal cancer.

The application seeks approval of biosimilar bevacizumab for treatment of patients with metastatic colorectal cancer in addition to other ailments.

“Once approved, our proposed biosimilar bevacizumab will provide an affordable alternative to the branded biologic for the approved indications. Biocon Biologics’ strong R&D and manufacturing capabilities have enabled us to offer two key biosimilars to cancer patients in the US and bevacizumab will further expand our oncology portfolio,” said Christiane Hamacher, chief executive officer (CEO), Biocon Biologics.

The biosimilar, the approval of which is expected by year-end, would be the third biosimilar from the partnered portfolio of Biocon and Mylan for cancer patients in the US. It is currently available in India and other developing markets.

Swiss drugmaker Roche markets bevacizumab under brand name Avastin. The drug had garnered about $7.3 billion in sales in 2019. Amgen and Allergan, too, had launched Mvasi, a bevacizumab biosimilar in the US last year and has been selling the product 15 per cent lower than Roche’s Avastin.

According to an EY report, India is likely to capture about 8 per cent of the global $62 billion biosimilar market by 2025. Biocon, in 2019, had earned 27 per cent of its overall revenue from biosimilars. The Bengaluru-based company has set an ambitious target of $1 billion in sales through its biologics division by FY22.

Biocon had, in December last year, launched trastuzumab biosimilar Ogivri in the US market, which is a biosimilar to herceptin, and was co-developed by Biocon Biologics and Mylan.

Herceptin has sales of around $2.9 billion in the US. The biosimilar, used to treat breast cancer and gastric cancer, was rolled out at a competitive discount for customers to help ensure access.

In 2018, too, Biocon had launched fulphila, a biosimilar pegfilgrastim, which is used to stimulate the bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy. Biocon Biologics currently has a product pipeline of 28 critical molecules, of which it partners with Mylan for 11 of them. According to experts, launch of another biosimilar, insulin glargine, likely in the US this year, could provide another booster dose to the Biocon-Mylan partnership.

US-headquartered Mylan has been following a partnership strategy with domestic companies, including Biocon and Natco, in order to control R&D costs. The company also pitches for the government to incentivise R&D activities in the country.

BOOSTER DOSE

Biocon and Mylan have a product pipeline of 11 biosimilars

2018: Pegfilgrastim biosimilar rolled out in US; treats infection in patients undergoing chemotherapy

2019: Trastuzumab biosimilar launched in US; treats breast cancer and gastric cancer

2020: Insulin glargine biosimilar likely to be approved in US in the second half of this year

Unichem gets USFDA approval for high blood pressure drug Chlorthalidone

Drug firm Unichem Laboratories has received approval from the US health regulator to market Chlorthalidone tablets, used to treat high blood pressure.

The company has received abbreviated new drug application (ANDA) approval from the US Food and Drug Administration (USFDA) for Chlorthalidone tablets USP in the strengths of 25 mg and 50 mg, Unichem Laboratories said in a regulatory filing.

The approved product is a generic version of Hygroton tablets, 25 mg and 50 mg of Sanofi Aventis US, LLC.

Hygroton tablets is indicated in the management of hypertension, either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension, Unichem Laboratories said.

It is also used as an adjunctive therapy in edema, associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy and the treatment of edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.

Unichem said the product will be commercialised from its Ghaziabad plant.

Lupin's Goa plant may face regulatory action, says USFDA after inspection

Drug maker Lupin on Monday said the US health regulator made two observations after inspection of its Goa plant and cautioned that the facility may be subject to regulatory action; and it may withhold approval of pending applications in which this facility is listed.

"The company has received a communication from the US Food and Drug Administration (USFDA), classifying the inspection conducted at its Goa facility between January 28 to February 8, 2019 as Official Action Indicated (OAI)... The inspection at the Goa facility had closed with two observations," Lupin said in a regulatory filing.

"The USFDA has stated that this facility may be subject to regulatory or administrative action and that it may withhold approval of any pending applications or supplements in which this facility is listed," the company added.

Based on USFDA's Concept of Operations program, the company said it understands that the status of the facility is still under review.

The Mumbai-based drug maker, however, said it does not believe that the classification would have an impact on disruption of supplies or the existing revenues from operations of this facility.

The company is in the process of sending further updates of its corrective actions to the USFDA and is hopeful of a positive outcome, it added.

Earlier, the USFDA had classified the inspection conducted at Pithampur facility and its Somerset (New Jersey) facility in April 2019 and December 2018, respectively, as OAI, which means approvals of pending applications or supplements from the site maybe withheld.

Shares of Lupin were trading 3.17 per cent lower at Rs 738.75 apiece on the BSE.

Lupin,Zydus Pharmaceuticals recall products in US, says USFDA report

Drug major Lupin is recalling 46,700 bottles of Morphine Sulfate extended-release tablets, used to treat severe pain, in the US market, according to a report by the US health regulator.

Lupin Somerset is recalling the drug in various strengths due to "failed impurities/degradation specifications", the latest enforcement report by the US Food and Drug Administration (USFDA) said.

"Product was shipped to five wholesalers and one supermarket chain who may have further distributed the product throughout the US," it added.

Zydus Pharmaceuticals USA Inc, a subsidiary of Zydus Cadila, is also recalling 7,668 bottles of Carvedilol Tablets, used to treat high blood pressure, in the American market.

The drug firm is recalling the drug due to the "presence of foreign tablets/capsules", the USFDA said.

"Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg," it added.

The USFDA classified both the recalls as Class III.

A Class III recall by the USFDA is initiated in a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.