Pharma & Healthcare
Glenmark, Strides Pharma, Cipla recall products in the US due to manufacturing issues
NEW DELHI, (PTI): Drug makers Glenmark, Strides Pharma and Cipla are recalling products in the US, the world’s largest market for medicines, due to manufacturing issues.
As per the latest Enforcement Report issued by the US Food and Drug Administration (USFDA), New Jersey-based Glenmark Pharmaceuticals Inc is recalling over 72,000 units of blood pressure lowering drug due to packaging issues.
The USFDA noted in its report that the company, a subsidiary of Mumbai-based drug firm, is recalling the affected lot due to ”blister package issues.” The lot was produced at Glenmark’s Pithampur (Madhya Pradesh) based manufacturing facility. The USFDA stated that Glenmark initiated the Class II nationwide (US) recall on June 29 this year.
In a separate note, the US health regulator said a unit of Bengaluru-based Strides Pharma Science is recalling 1,032 bottles of Prednisone tablets, a medication used to treat many conditions including asthma, allergic reactions, arthritis, inflammatory bowel diseases, among others.
The affected lot was produced by Strides Pharma Science and marketed in the US by New Jersey-based Strides Pharma Inc. As per the USFDA, the company is recalling the affected lot due to ”presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone tablets”. The company initiated the Class II voluntary nationwide recall on July 19 this year.
As per the USFDA, homegrown drug major Cipla is recalling 7,992 bottles of Difluprednate Ophthalmic Emulsion, used to treat swelling and pain after eye surgery, in the US market.
New Jersey-based Cipla USA, Inc, a unit of Mumbai-based drug maker, is recalling the lot due to ”lack of assurance of sterility”, the USFDA stated.
There were complaints regarding ”defective container closure,” it added. The affected lot was manufactured in India and marketed in the US by Cipla USA, Inc.
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.
The US is by far the largest market for pharmaceutical products in the world. In the last financial year, India’s pharma exports stood at around USD 24.62 billion with the US, UK, South Africa, Russia, and Nigeria emerging as the top five destinations. (PTI)
Pharma & Healthcare
Is it safe for patients with heart disease to have sex? How can Active EECP help cardiac patients achieve a fulfilling sex life?
MUMBAI: Among the many questions asked by my heart patients in Mumbai, is whether heart ailments, or cardiovascular disease can affect one’s sex life, to what extent and is it safe to have sex at all if you are suffering from some form of heart disease or ailment, says Active EECP and heart specialist Dr Pranav Kabra with the Raksha Multispeciality Hospital in suburban Mumbai.
According to Dr Pranav Kabra, “It is reasonably safe for a heart patient to have sex if the cardiovascular condition is stabilized and under control with no major danger signs or signals from the body.”
“Regular and fulfilling sexual activity is part of human existence and a major quality of life issue, both for men and women and equally affects the patient as well as their partners over time,” opines Dr Pranav Kabra.
Cardiovascular issues and events — such as a heart attack, irregular heart beat, acute chest pain caused by heart disease — hardly or rarely occur during sexual activity, because sexual activity is usually for a short time from 10 to 20 minutes.
“At this stage, I would recommend patients with heart disease go in for Active EECP treatment to minimize or completely cure cardiac related problems,” Dr Kabra opines.
“Some patients tend to postpone sexual activity to when it is relatively safe for them to indulge in it,” while on the other hand, there are other patients for whom it may be advisable to defer sexual activity until they’re stabilized and their heart condition is under control,” suggests Dr Kabra, adding that Active EECP treatment can help heart patients show drastic improvement in their cardiac condition.
Sexual dysfunction due to heart ailments is directly related to the severity of cardiovascular disease.
When patients resumed sexual activity, those with severe heart disease reported significant difficulty, including a lack of interest in sex, sexual dissatisfaction and a decrease in the frequency of sexual activity. These factors and issues can be remedied to a great extent by Active EECP therapy that leads to a better sense of fulfillment, aiding in a better life experience.
If you have unstable or non-controllable cardiovascular disease or if your symptoms are severe, you should be treated and stabilized before indulging in sexual activity, opines Dr Kabra using Active EECP therapy that can help avoid a bypass or other surgical methods to treat cardiac ailments.
Active EECP therapy helps patients will physical and cardiac ailments, including problems like obesity, erectile dysfunction, premature ejaculation and other sexual problems caused by high blood pressure, etc., achieve a fulfilling sex life
Pharma & Healthcare
Zenara Pharma launches nirmatrelvir, ritonavir tablets for COVID-19 patients
NEW DELHI, (PTI): Zenara Pharma on Friday announced the launch of nirmatrelvir and ritonavir tablets in a combination pack to be used as a treatment option for patients with mild-to-moderate symptoms of COVID-19.
The company received approval from the Central Drugs Standard Control Organization (CDSCO) to manufacture and market this product last month, Zenara Pharma said in a statement.
The drug will be sold under the brand name ‘Paxzen’ and is priced at Rs 5,200 per pack containing 20 tablets of nirmatrelvir 150 mg and 10 tablets of ritonavir 100 mg, which is equivalent to one full course of treatment for a patient, it added.
It will be manufactured at Zenara’s USFDA and EU-approved facility in Hyderabad, the company said.
”Our product Paxzen has been proven equivalent to Paxlovid through a bioequivalence study, based on which we have received the approval from the regulatory authorities,” Zenara Pharma co-founder and Managing Director, Jagadeesh Babu Rangisetty said.
The USFDA had approved Paxlovid in December 2021 and is indicated for the treatment of mild-to-moderate COVID-19 in adults, the company added. (PTI)
Pharma & Healthcare
Intercept Pharmaceuticals settles Ocaliva patent litigation case with Dr Reddy’s
HYDERABAD, (PTI): August 19, 2022: Intercept Pharmaceuticals Inc has said it entered into a settlement agreement with Dr Reddy’s Laboratories resolving the previously disclosed patent litigation to market a generic version of Ocaliva (obeticholic acid) 5 mg and 10 mg tablets in the USA.
Ocaliva is used to treat a rare, chronic liver disease known as primary biliary cholangitis (PBC).
”Under the terms of the agreement, Intercept granted Dr. Reddy’s a non-exclusive, non-sublicensable, non-transferable, royalty-free licence to commercialize its generic version of Ocaliva in the United States commencing on October 26, 2035, or earlier under certain circumstances,” Intercept Pharmaceuticals in a regulatory filing said.
Similar patent litigation previously disclosed by the company against five other ANDA (Abbreviated New Drug Application) filers seeking approval to market generic Ocaliva remains pending, it further said.
For the full year 2021, Ocaliva net sales were USD 363.5 million including USA net sales of USD 260.8 million, which represented growth of 16 per cent as compared to the prior year.
In May 2020, Dr Reddy’s said it has launched the generic version of Ocaliva in the Indian market. (PTI)
Pharma & Healthcare
Strides Pharma Science arm gets USFDA nod for generic naproxen sodium softgel capsules
MUMBAI, (PTI): August 18, 2022: Strides Pharma Science Ltd on Thursday said its wholly-owned arm, Strides Pharma Global Pte Ltd, has received approval from the US health regulator for generic naproxen sodium softgel capsules, used to treat pain or inflammation.
The approval by the US Food & Drug Administration (USFDA) is for naproxen sodium softgel capsules of 220 mg strength (over the counter), the company said in a regulatory filing.
It is bioequivalent and therapeutically equivalent to the reference-listed drug, naproxen sodium capsules, 220 mg of Bionpharma Inc, it added.
The product will be manufactured at the company’s Bengaluru facility.
Naproxen sodium softgel capsules is a nonsteroidal anti-inflammatory drug used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps, the company said.
Strides said it is focusing on building a private label business in the US by leveraging its portfolio of products across soft gels, tablets, capsules and other formats.
The US over the counter (OTC) market for naproxen sodium softgel capsules, 220 mg, is approximately USD 100 million, the company said. (PTI)